Who is sponsoring NCT01643928?

NCT01643928 is sponsored by Pfizer.

What drugs are being tested in NCT01643928?

Interventions in NCT01643928: Rituximab-Pfizer (PF-05280586) x 3 courses, Rituximab-EU+ Rituximab-Pfizer x 2 Courses, Rituximab-US + Rituximab-Pfizer x 2 Courses.

What condition does NCT01643928 study?

NCT01643928 studies Rheumatoid Arthritis.

Is NCT01643928 still recruiting?

NCT01643928 is currently completed. Last updated 29 January 2019.

Are results published for NCT01643928?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-01-29 · How we verify

NCT01643928

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Rheumatoid Arthritis Extension Trial For Subjects Who Have Participated In Other PF-05280586 Trials (REFLECTIONS B328-04)

Completed NA Results posted Last updated 29 January 2019

What this trial tests

NA trial testing Rituximab-Pfizer (PF-05280586) x 3 courses in Rheumatoid Arthritis in 185 participants. Completed in 14 March 2016.

Timeline

16 August 2012

Primary endpoint
14 March 2016

14 March 2016

Quick facts

Lead sponsor	Pfizer
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Masking	triple
Primary purpose	treatment
Enrollment	185
Start date	16 August 2012
Primary completion	14 March 2016
Estimated completion	14 March 2016
Sites	71 locations across Colombia, South Africa, Russia, United Kingdom, Germany, Israel, Mexico, Canada

Drugs / interventions tested

Rituximab-Pfizer (PF-05280586) x 3 courses — full drug profile →
Rituximab-EU+ Rituximab-Pfizer x 2 Courses — full drug profile →
Rituximab-US + Rituximab-Pfizer x 2 Courses — full drug profile →

Conditions studied

Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay Primary · Course 1 (C1) Overall, Course 2 (C2) Overall, Course 3 (C3) Overall, and All Courses Overall.

Serum samples were collected to determine the presence of ADA using two validated assays, one specific for PF-05280586 and one specific for the licensed drug products. For participants assigned to PF-05280586 in Study B3281001, blood samples were screened for ADA using the assay specific to PF-05280586; if the blood samples were confirmed to be positive (+ve) for ADA against PF-05280586, the samples were also analyzed using the assay specific for the licensed drug products to assess cross-reactivity of the ADA. For participants assigned to the licensed products in Study B3281001, blood samples

Total (C1) +ve

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	3.5
Rituximab-EU/PF-05280586/PF-05280586	0.0
PF-05280586/PF-05280586/PF-05280586 (EU)	15.2
Rituximab-EU Total	7.8
Rituximab-US/PF-05280586/PF-05280586	13.3
PF-05280586/PF-05280586/PF-05280586 (US)	6.7
Rituximab-US Total	10.0

Total (C2) +ve

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	5.7
Rituximab-EU/PF-05280586/PF-05280586	3.3
PF-05280586/PF-05280586/PF-05280586 (EU)	0.0
Rituximab-EU Total	1.6
Rituximab-US/PF-05280586/PF-05280586	0.0
PF-05280586/PF-05280586/PF-05280586 (US)	6.9
Rituximab-US Total	3.4

Total (C3) +ve

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	2.1
Rituximab-EU/PF-05280586/PF-05280586	0.0
PF-05280586/PF-05280586/PF-05280586 (EU)	0.0
Rituximab-EU Total	0.0
Rituximab-US/PF-05280586/PF-05280586	0.0
PF-05280586/PF-05280586/PF-05280586 (US)	0.0
Rituximab-US Total	0.0

C1 to C3 +ve

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	8.6
Rituximab-EU/PF-05280586/PF-05280586	3.1
PF-05280586/PF-05280586/PF-05280586 (EU)	15.2
Rituximab-EU Total	9.2
Rituximab-US/PF-05280586/PF-05280586	13.3
PF-05280586/PF-05280586/PF-05280586 (US)	6.7
Rituximab-US Total	10.0

Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay Primary · Course 1 Overall, Course 2 Overall, Course 3 Overall, and All Courses Overall.

Serum samples were collected to determine the presence of ADA using two validated assays, one specific for PF-05280586 and one specific for the licensed drug products. For participants assigned to PF-05280586 in Study B3281001, blood samples were screened for ADA using the assay specific to PF-05280586; if the blood samples were confirmed to be positive for ADA against PF-05280586, the samples were also analyzed using the assay specific for the licensed drug products to assess cross-reactivity of the ADA. For participants assigned to the licensed products in Study B3281001, blood samples were

Total (C1) +ve

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	3.5
Rituximab-EU/PF-05280586/PF-05280586	3.2
PF-05280586/PF-05280586/PF-05280586 (EU)	15.2
Rituximab-EU Total	9.4
Rituximab-US/PF-05280586/PF-05280586	10.0
PF-05280586/PF-05280586/PF-05280586 (US)	10.0
Rituximab-US Total	10.0

Total (C2) +ve

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	5.7
Rituximab-EU/PF-05280586/PF-05280586	6.7
PF-05280586/PF-05280586/PF-05280586 (EU)	3.2
Rituximab-EU Total	4.9
Rituximab-US/PF-05280586/PF-05280586	3.4
PF-05280586/PF-05280586/PF-05280586 (US)	13.8
Rituximab-US Total	8.6

Total (C3) +ve

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	2.1
Rituximab-EU/PF-05280586/PF-05280586	0.0
PF-05280586/PF-05280586/PF-05280586 (EU)	3.3
Rituximab-EU Total	1.7
Rituximab-US/PF-05280586/PF-05280586	0.0
PF-05280586/PF-05280586/PF-05280586 (US)	3.4
Rituximab-US Total	1.8

C1 to C3 +ve

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	8.6
Rituximab-EU/PF-05280586/PF-05280586	6.3
PF-05280586/PF-05280586/PF-05280586 (EU)	18.2
Rituximab-EU Total	12.3
Rituximab-US/PF-05280586/PF-05280586	13.3
PF-05280586/PF-05280586/PF-05280586 (US)	13.3
Rituximab-US Total	13.3

Mean Rituximab Serum Trough Concentrations Primary · Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3), Follow up Months 3, 6, 9, and 12. Course 3/Week 25 is End of Treatment (EOT).

Serum samples for determination of drug concentrations were collected pre-dose concurrent with ADA sample collection. Drug concentrations in the samples were determined using a validated assay.

Course 1/Week 1

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	636.5	± 816.33
Rituximab-EU/PF-05280586/PF-05280586	855.5	± 1594.51
PF-05280586/PF-05280586/PF-05280586 (EU)	416.6	± 615.86
Rituximab-US/PF-05280586/PF-05280586	1525.8	± 3709.90
PF-05280586/PF-05280586/PF-05280586 (US)	980.0	± 2091.41

Course 1/Week 3

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	103019.3	± 29250.13
Rituximab-EU/PF-05280586/PF-05280586	114341.9	± 39023.45
PF-05280586/PF-05280586/PF-05280586 (EU)	89790.9	± 23247.03
Rituximab-US/PF-05280586/PF-05280586	96323.3	± 33396.81
PF-05280586/PF-05280586/PF-05280586 (US)	107790.0	± 26168.99

Course 1/Week 13

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	22613.1	± 16526.33
Rituximab-EU/PF-05280586/PF-05280586	27542.3	± 18879.35
PF-05280586/PF-05280586/PF-05280586 (EU)	16973.6	± 10736.22
Rituximab-US/PF-05280586/PF-05280586	26359.8	± 27063.70
PF-05280586/PF-05280586/PF-05280586 (US)	31006.6	± 23055.79

Course 1/Week 25

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	2844.2	± 4271.65
Rituximab-EU/PF-05280586/PF-05280586	3573.3	± 3569.90
PF-05280586/PF-05280586/PF-05280586 (EU)	1719.3	± 3383.03
Rituximab-US/PF-05280586/PF-05280586	8205.1	± 9923.43
PF-05280586/PF-05280586/PF-05280586 (US)	3005.6	± 5227.33

Course 2/Week 1

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	1628.2	± 2712.30
Rituximab-EU/PF-05280586/PF-05280586	2493.2	± 3631.38
PF-05280586/PF-05280586/PF-05280586 (EU)	924.1	± 1546.20
Rituximab-US/PF-05280586/PF-05280586	3463.6	± 5311.01
PF-05280586/PF-05280586/PF-05280586 (US)	3596.1	± 5514.43

Course 2/Week 3

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	108064.2	± 37043.94
Rituximab-EU/PF-05280586/PF-05280586	114266.7	± 29897.86
PF-05280586/PF-05280586/PF-05280586 (EU)	91006.7	± 23725.24
Rituximab-US/PF-05280586/PF-05280586	102937.9	± 29824.58
PF-05280586/PF-05280586/PF-05280586 (US)	114992.6	± 31832.89

Course 2/Week 13

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	26527.9	± 17903.00
Rituximab-EU/PF-05280586/PF-05280586	31829.7	± 17954.12
PF-05280586/PF-05280586/PF-05280586 (EU)	21467.0	± 11390.72
Rituximab-US/PF-05280586/PF-05280586	27730.7	± 21932.00
PF-05280586/PF-05280586/PF-05280586 (US)	36007.9	± 23651.20

Course 2/Week 25

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	3431.9	± 4155.80
Rituximab-EU/PF-05280586/PF-05280586	4074.2	± 5043.55
PF-05280586/PF-05280586/PF-05280586 (EU)	1375.8	± 1507.10
Rituximab-US/PF-05280586/PF-05280586	5103.3	± 5344.88
PF-05280586/PF-05280586/PF-05280586 (US)	5228.6	± 7171.47

Cluster of Differentiation 19 (CD19+) B Cell Count Primary · Weeks 1, 6, 13, and 25 (Course 1 and Course 2), Weeks 1, 13, 25 (Course 3), and Follow up Months 3, 6, and 9.

Blood samples were assayed for CD19+ B-cell counts using laser scanning cytometry.

Course 1/Week 1

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	0.0	0.0 – 109.2
Rituximab-EU/PF-05280586/PF-05280586	1.1	0.0 – 105.6
PF-05280586/PF-05280586/PF-05280586 (EU)	0.6	0.0 – 55.9
Rituximab-US/PF-05280586/PF-05280586	0.0	0.0 – 115.9
PF-05280586/PF-05280586/PF-05280586 (US)	0.6	0.0 – 677.5

Course 1/Week 6

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	0.0	0.0 – 0.0
Rituximab-EU/PF-05280586/PF-05280586	0.0	0.0 – 16.7
PF-05280586/PF-05280586/PF-05280586 (EU)	0.0	0.0 – 0.6
Rituximab-US/PF-05280586/PF-05280586	0.0	0.0 – 1.8
PF-05280586/PF-05280586/PF-05280586 (US)	0.0	0.0 – 9.2

Course 1/Week 13

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	0.0	0.0 – 0.2
Rituximab-EU/PF-05280586/PF-05280586	0.0	0.0 – 34.9
PF-05280586/PF-05280586/PF-05280586 (EU)	0.0	0.0 – 4.2
Rituximab-US/PF-05280586/PF-05280586	0.0	0.0 – 0.4
PF-05280586/PF-05280586/PF-05280586 (US)	0.0	0.0 – 10.3

Course 1/Week 25

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	0.0	0.0 – 27.9
Rituximab-EU/PF-05280586/PF-05280586	0.0	0.0 – 62.7
PF-05280586/PF-05280586/PF-05280586 (EU)	0.0	0.0 – 67.9
Rituximab-US/PF-05280586/PF-05280586	0.0	0.0 – 123.4
PF-05280586/PF-05280586/PF-05280586 (US)	0.0	0.0 – 0.0

Course 2/Week 1

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	0.0	0.0 – 146.1
Rituximab-EU/PF-05280586/PF-05280586	0.0	0.0 – 164.0
PF-05280586/PF-05280586/PF-05280586 (EU)	0.0	0.0 – 77.3
Rituximab-US/PF-05280586/PF-05280586	0.0	0.0 – 89.1
PF-05280586/PF-05280586/PF-05280586 (US)	0.0	0.0 – 79.8

Course 2/Week 6

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	0.0	0.0 – 410.3
Rituximab-EU/PF-05280586/PF-05280586	0.0	0.0 – 1.5
PF-05280586/PF-05280586/PF-05280586 (EU)	0.0	0.0 – 13.3
Rituximab-US/PF-05280586/PF-05280586	0.0	0.0 – 0.8
PF-05280586/PF-05280586/PF-05280586 (US)	0.0	0.0 – 0.5

Course 2/Week 13

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	0.0	0.0 – 8.6
Rituximab-EU/PF-05280586/PF-05280586	0.0	0.0 – 1.7
PF-05280586/PF-05280586/PF-05280586 (EU)	0.0	0.0 – 13.8
Rituximab-US/PF-05280586/PF-05280586	0.0	0.0 – 0.6
PF-05280586/PF-05280586/PF-05280586 (US)	0.0	0.0 – 16.7

Course 2/Week 25

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	0.0	0.0 – 7.7
Rituximab-EU/PF-05280586/PF-05280586	0.0	0.0 – 68.4
PF-05280586/PF-05280586/PF-05280586 (EU)	0.0	0.0 – 11.3
Rituximab-US/PF-05280586/PF-05280586	0.0	0.0 – 1.7
PF-05280586/PF-05280586/PF-05280586 (US)	0.0	0.0 – 9.6

Circulating Immunoglobulin G (IgG) Concentrations Primary · Screening, Week 25 (Course 1), and Weeks 1 and 25 (Course 2 and Course 3).

Blood samples for immunoglobulin assessments were obtained to determine IgG levels in serum.

Screening

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	11.7	± 3.06
Rituximab-EU/PF-05280586/PF-05280586	10.9	± 2.54
PF-05280586/PF-05280586/PF-05280586 (EU)	11.6	± 2.85
Rituximab-US/PF-05280586/PF-05280586	11.3	± 3.12
PF-05280586/PF-05280586/PF-05280586 (US)	11.8	± 3.52

Course 1/Week 25

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	10.4	± 3.20
Rituximab-EU/PF-05280586/PF-05280586	10.7	± 3.71
PF-05280586/PF-05280586/PF-05280586 (EU)	11.2	± 2.50
Rituximab-US/PF-05280586/PF-05280586	10.3	± 3.50
PF-05280586/PF-05280586/PF-05280586 (US)	11.4	± 3.92

Course 2/Week 1

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	10.5	± 2.73
Rituximab-EU/PF-05280586/PF-05280586	10.2	± 2.78
PF-05280586/PF-05280586/PF-05280586 (EU)	10.8	± 2.55
Rituximab-US/PF-05280586/PF-05280586	10.2	± 2.29
PF-05280586/PF-05280586/PF-05280586 (US)	10.9	± 3.59

Course 2/Week 25

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	10.6	± 2.85
Rituximab-EU/PF-05280586/PF-05280586	8.9	± 2.40
PF-05280586/PF-05280586/PF-05280586 (EU)	10.4	± 2.11
Rituximab-US/PF-05280586/PF-05280586	9.2	± 2.00
PF-05280586/PF-05280586/PF-05280586 (US)	11.4	± 4.08

Course 3/Week 1

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	10.6	± 2.92
Rituximab-EU/PF-05280586/PF-05280586	10.2	± 2.61
PF-05280586/PF-05280586/PF-05280586 (EU)	10.6	± 2.81
Rituximab-US/PF-05280586/PF-05280586	9.7	± 2.44
PF-05280586/PF-05280586/PF-05280586 (US)	10.3	± 3.88

Course 3/Week 25 (EOT)

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	10.4	± 2.86
Rituximab-EU/PF-05280586/PF-05280586	9.8	± 3.04
PF-05280586/PF-05280586/PF-05280586 (EU)	10.3	± 2.34
Rituximab-US/PF-05280586/PF-05280586	9.7	± 2.30
PF-05280586/PF-05280586/PF-05280586 (US)	10.2	± 3.25

Circulating Immunoglobulin M (IgM) Concentrations Primary · Screening, Week 25 (Course 1), and Weeks 1 and 25 (Course 2 and Course 3).

Blood samples for immunoglobulin assessments were obtained to determine IgM levels in serum.

Screening

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	1.0	± 0.50
Rituximab-EU/PF-05280586/PF-05280586	1.1	± 0.73
PF-05280586/PF-05280586/PF-05280586 (EU)	1.1	± 0.70
Rituximab-US/PF-05280586/PF-05280586	1.1	± 0.79
PF-05280586/PF-05280586/PF-05280586 (US)	1.0	± 0.57

Course 1/Week 25

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	0.8	± 0.47
Rituximab-EU/PF-05280586/PF-05280586	1.1	± 0.62
PF-05280586/PF-05280586/PF-05280586 (EU)	0.9	± 0.60
Rituximab-US/PF-05280586/PF-05280586	1.0	± 0.72
PF-05280586/PF-05280586/PF-05280586 (US)	0.9	± 0.45

Course 2/Week 1

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	0.8	± 0.48
Rituximab-EU/PF-05280586/PF-05280586	0.9	± 0.56
PF-05280586/PF-05280586/PF-05280586 (EU)	0.9	± 0.64
Rituximab-US/PF-05280586/PF-05280586	0.9	± 0.61
PF-05280586/PF-05280586/PF-05280586 (US)	0.8	± 0.47

Course 2/Week 25

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	0.8	± 0.55
Rituximab-EU/PF-05280586/PF-05280586	0.8	± 0.46
PF-05280586/PF-05280586/PF-05280586 (EU)	0.9	± 0.64
Rituximab-US/PF-05280586/PF-05280586	0.9	± 0.63
PF-05280586/PF-05280586/PF-05280586 (US)	0.8	± 0.50

Course 3/Week 1

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	0.8	± 0.43
Rituximab-EU/PF-05280586/PF-05280586	0.8	± 0.46
PF-05280586/PF-05280586/PF-05280586 (EU)	0.8	± 0.57
Rituximab-US/PF-05280586/PF-05280586	0.8	± 0.52
PF-05280586/PF-05280586/PF-05280586 (US)	0.7	± 0.40

Course 3/Week 25 (EOT)

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	0.7	± 0.39
Rituximab-EU/PF-05280586/PF-05280586	0.7	± 0.44
PF-05280586/PF-05280586/PF-05280586 (EU)	0.8	± 0.54
Rituximab-US/PF-05280586/PF-05280586	0.8	± 0.52
PF-05280586/PF-05280586/PF-05280586 (US)	0.7	± 0.38

Circulating Rheumatoid Factor (RF) Concentrations Primary · Week 1 and 25 (Course 1, Course 2, and Course 3).

RF is the auto-antibody directed against IgG. Blood samples were obtained to determine RF levels in serum.

Course 1/Week 1

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	105.6	± 203.88
Rituximab-EU/PF-05280586/PF-05280586	431.3	± 1074.13
PF-05280586/PF-05280586/PF-05280586 (EU)	128.7	± 201.11
Rituximab-US/PF-05280586/PF-05280586	75.2	± 102.41
PF-05280586/PF-05280586/PF-05280586 (US)	109.1	± 139.79

Course 1/Week 25

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	56.1	± 104.12
Rituximab-EU/PF-05280586/PF-05280586	714.8	± 1471.95
PF-05280586/PF-05280586/PF-05280586 (EU)	101.5	± 165.85
Rituximab-US/PF-05280586/PF-05280586	53.2	± 59.22
PF-05280586/PF-05280586/PF-05280586 (US)	66.5	± 69.70

Course 2/Week 1

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	92.6	± 181.91
Rituximab-EU/PF-05280586/PF-05280586	279.3	± 737.00
PF-05280586/PF-05280586/PF-05280586 (EU)	132.9	± 234.84
Rituximab-US/PF-05280586/PF-05280586	59.5	± 76.56
PF-05280586/PF-05280586/PF-05280586 (US)	58.6	± 73.13

Course 2/Week 25

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	59.5	± 117.79
Rituximab-EU/PF-05280586/PF-05280586	448.0	± 945.12
PF-05280586/PF-05280586/PF-05280586 (EU)	62.4	± 89.14
Rituximab-US/PF-05280586/PF-05280586	52.0	± 54.97
PF-05280586/PF-05280586/PF-05280586 (US)	44.2	± 44.34

Course 3/Week 1

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	51.7	± 89.51
Rituximab-EU/PF-05280586/PF-05280586	217.3	± 697.30
PF-05280586/PF-05280586/PF-05280586 (EU)	74.9	± 128.83
Rituximab-US/PF-05280586/PF-05280586	51.8	± 92.06
PF-05280586/PF-05280586/PF-05280586 (US)	40.4	± 45.90

Course 3/Week 25 (EOT)

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	46.2	± 76.85
Rituximab-EU/PF-05280586/PF-05280586	181.2	± 551.49
PF-05280586/PF-05280586/PF-05280586 (EU)	57.1	± 107.47
Rituximab-US/PF-05280586/PF-05280586	45.0	± 66.43
PF-05280586/PF-05280586/PF-05280586 (US)	38.2	± 41.46

Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement Primary · Week 1 and 25 (Course 1, Course 2, and Course 3).

Blood samples were obtained to determine anti-CCP and compliment levels in serum.

Course 1/Week 1

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	293.7	± 206.64
Rituximab-EU/PF-05280586/PF-05280586	346.1	± 206.78
PF-05280586/PF-05280586/PF-05280586 (EU)	311.5	± 198.13
Rituximab-US/PF-05280586/PF-05280586	223.9	± 224.86
PF-05280586/PF-05280586/PF-05280586 (US)	306.1	± 210.82

Course 1/Week 25

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	266.9	± 222.12
Rituximab-EU/PF-05280586/PF-05280586	230.8	± 207.06
PF-05280586/PF-05280586/PF-05280586 (EU)	300.9	± 199.02
Rituximab-US/PF-05280586/PF-05280586	258.0	± 227.91
PF-05280586/PF-05280586/PF-05280586 (US)	263.6	± 190.26

Course 2/Week 1

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	285.7	± 211.65
Rituximab-EU/PF-05280586/PF-05280586	305.2	± 208.41
PF-05280586/PF-05280586/PF-05280586 (EU)	324.6	± 196.92
Rituximab-US/PF-05280586/PF-05280586	241.5	± 229.00
PF-05280586/PF-05280586/PF-05280586 (US)	262.2	± 210.17

Course 2/Week 25

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	259.0	± 224.11
Rituximab-EU/PF-05280586/PF-05280586	332.0	± 184.78
PF-05280586/PF-05280586/PF-05280586 (EU)	273.3	± 188.63
Rituximab-US/PF-05280586/PF-05280586	230.1	± 232.38
PF-05280586/PF-05280586/PF-05280586 (US)	237.9	± 204.70

Course 3/Week 1

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	270.0	± 213.62
Rituximab-EU/PF-05280586/PF-05280586	290.2	± 200.75
PF-05280586/PF-05280586/PF-05280586 (EU)	308.3	± 189.51
Rituximab-US/PF-05280586/PF-05280586	214.3	± 228.46
PF-05280586/PF-05280586/PF-05280586 (US)	234.6	± 212.97

Course 3/Week 25 (EOT)

Group	Value	95% CI
PF-05280586/PF-05280586/PF-05280586	249.6	± 212.37
Rituximab-EU/PF-05280586/PF-05280586	250.4	± 190.55
PF-05280586/PF-05280586/PF-05280586 (EU)	265.7	± 207.79
Rituximab-US/PF-05280586/PF-05280586	214.4	± 222.43
PF-05280586/PF-05280586/PF-05280586 (US)	245.1	± 207.29

Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1 Primary · Baseline B3281001, Week 1, 6, 13, and 25 (Course 1).

The disease activity score (DAS) assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis Visual Analog Scale (VAS). The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP equals (=) 0.56 square root (sqrt) (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 natural log \[ln\] (CRP \[milligrams per liter, mg/L\] +1) + 0.014 (global assessment of health \[GH\]) + 0.96

Baseline B3281001

Group	Value	95% CI
PF-05280586: by the End of Course 1	5.59	± 0.862
Rituximab-EU: by the End of Course 1	5.81	± 0.926
PF-05280586 (EU): by the End of Course 1	5.80	± 0.988
Rituximab-US: by the End of Course 1	6.16	± 0.870
PF-05280586 (US): by the End of Course 1	6.12	± 0.784

Change at Course 1/Week 1

Group	Value	95% CI
PF-05280586: by the End of Course 1	-1.24	± 1.126
Rituximab-EU: by the End of Course 1	-1.86	± 1.223
PF-05280586 (EU): by the End of Course 1	-1.94	± 1.315
Rituximab-US: by the End of Course 1	-2.02	± 1.508
PF-05280586 (US): by the End of Course 1	-1.95	± 1.211

Change at Course 1/Week 6

Group	Value	95% CI
PF-05280586: by the End of Course 1	-2.03	± 1.378
Rituximab-EU: by the End of Course 1	-2.59	± 1.088
PF-05280586 (EU): by the End of Course 1	-2.54	± 1.322
Rituximab-US: by the End of Course 1	-2.50	± 1.454
PF-05280586 (US): by the End of Course 1	-2.66	± 1.226

Change at Course 1/Week 13

Group	Value	95% CI
PF-05280586: by the End of Course 1	-2.37	± 1.134
Rituximab-EU: by the End of Course 1	-2.78	± 1.355
PF-05280586 (EU): by the End of Course 1	-2.66	± 1.439
Rituximab-US: by the End of Course 1	-2.85	± 1.368
PF-05280586 (US): by the End of Course 1	-2.76	± 1.200

Change at Course 1/Week 25

Group	Value	95% CI
PF-05280586: by the End of Course 1	-2.35	± 1.310
Rituximab-EU: by the End of Course 1	-2.32	± 1.166
PF-05280586 (EU): by the End of Course 1	-2.24	± 1.182
Rituximab-US: by the End of Course 1	-2.15	± 1.109
PF-05280586 (US): by the End of Course 1	-2.50	± 1.179

Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 Primary · Baseline B3281001, Week 1, 6, 13, and 25 (Course 1 and Course 2).

Baseline B3281001

Group	Value	95% CI
PF-05280586: by the End of Course 2	5.59	± 0.893
Rituximab-EU/PF-05280586: by the End of Course 2	5.81	± 0.956
PF-05280586 (EU): by the End of Course 2	5.77	± 1.009
Rituximab-US/PF-05280586: by the End of Course 2	6.13	± 0.865
PF-05280586 (US): by the End of Course 2	6.10	± 0.792

Change at Course 1/Week 1

Group	Value	95% CI
PF-05280586: by the End of Course 2	-1.27	± 1.120
Rituximab-EU/PF-05280586: by the End of Course 2	-1.82	± 1.257
PF-05280586 (EU): by the End of Course 2	-1.92	± 1.147
Rituximab-US/PF-05280586: by the End of Course 2	-1.93	± 1.466
PF-05280586 (US): by the End of Course 2	-1.99	± 1.218

Change at Course 1/Week 6

Group	Value	95% CI
PF-05280586: by the End of Course 2	-2.11	± 1.353
Rituximab-EU/PF-05280586: by the End of Course 2	-2.56	± 1.091
PF-05280586 (EU): by the End of Course 2	-2.53	± 1.205
Rituximab-US/PF-05280586: by the End of Course 2	-2.44	± 1.441
PF-05280586 (US): by the End of Course 2	-2.71	± 1.211

Change at Course 1/Week 13

Group	Value	95% CI
PF-05280586: by the End of Course 2	-2.41	± 1.110
Rituximab-EU/PF-05280586: by the End of Course 2	-2.78	± 1.355
PF-05280586 (EU): by the End of Course 2	-2.67	± 1.315
Rituximab-US/PF-05280586: by the End of Course 2	-2.76	± 1.318
PF-05280586 (US): by the End of Course 2	-2.76	± 1.200

Change at Course 1/Week 25

Group	Value	95% CI
PF-05280586: by the End of Course 2	-2.35	± 1.310
Rituximab-EU/PF-05280586: by the End of Course 2	-2.32	± 1.166
PF-05280586 (EU): by the End of Course 2	-2.19	± 1.034
Rituximab-US/PF-05280586: by the End of Course 2	-2.02	± 1.038
PF-05280586 (US): by the End of Course 2	-2.50	± 1.179

Change at Course 2/Week 1

Group	Value	95% CI
PF-05280586: by the End of Course 2	-1.98	± 1.480
Rituximab-EU/PF-05280586: by the End of Course 2	-2.05	± 1.275
PF-05280586 (EU): by the End of Course 2	-1.92	± 1.132
Rituximab-US/PF-05280586: by the End of Course 2	-2.20	± 1.295
PF-05280586 (US): by the End of Course 2	-2.34	± 1.036

Change at Course 2/Week 6

Group	Value	95% CI
PF-05280586: by the End of Course 2	-2.66	± 1.177
Rituximab-EU/PF-05280586: by the End of Course 2	-2.74	± 1.552
PF-05280586 (EU): by the End of Course 2	-2.75	± 1.148
Rituximab-US/PF-05280586: by the End of Course 2	-2.92	± 1.231
PF-05280586 (US): by the End of Course 2	-3.00	± 1.089

Change at Course 2/Week 13

Group	Value	95% CI
PF-05280586: by the End of Course 2	-2.35	± 1.319
Rituximab-EU/PF-05280586: by the End of Course 2	-2.56	± 1.644
PF-05280586 (EU): by the End of Course 2	-2.65	± 1.113
Rituximab-US/PF-05280586: by the End of Course 2	-2.88	± 1.476
PF-05280586 (US): by the End of Course 2	-3.21	± 1.135

Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 Primary · Baseline B3281001, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).

Baseline B3281001

Group	Value	95% CI
PF-05280586: by the End of Course 3	5.54	± 0.896
Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3	5.81	± 0.956
PF-05280586 (EU): by the End of Course 3	5.79	± 1.019
Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3	6.14	± 0.886
PF-05280586 (US): by the End of Course 3	6.10	± 0.792

Change at Course 1/Week 1

Group	Value	95% CI
PF-05280586: by the End of Course 3	-1.25	± 1.158
Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3	-1.82	± 1.257
PF-05280586 (EU): by the End of Course 3	-1.86	± 1.121
Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3	-2.01	± 1.438
PF-05280586 (US): by the End of Course 3	-1.99	± 1.218

Change at Course 1/Week 6

Group	Value	95% CI
PF-05280586: by the End of Course 3	-2.10	± 1.380
Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3	-2.56	± 1.091
PF-05280586 (EU): by the End of Course 3	-2.51	± 1.221
Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3	-2.53	± 1.438
PF-05280586 (US): by the End of Course 3	-2.71	± 1.211

Change at Course 1/Week 13

Group	Value	95% CI
PF-05280586: by the End of Course 3	-2.47	± 1.101
Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3	-2.78	± 1.355
PF-05280586 (EU): by the End of Course 3	-2.64	± 1.322
Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3	-2.82	± 1.284
PF-05280586 (US): by the End of Course 3	-2.76	± 1.200

Change at Course 1/Week 25

Group	Value	95% CI
PF-05280586: by the End of Course 3	-2.25	± 1.293
Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3	-2.32	± 1.166
PF-05280586 (EU): by the End of Course 3	-2.12	± 1.023
Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3	-2.21	± 0.848
PF-05280586 (US): by the End of Course 3	-2.50	± 1.179

Change at Course 2/Week 1

Group	Value	95% CI
PF-05280586: by the End of Course 3	-1.93	± 1.500
Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3	-2.05	± 1.275
PF-05280586 (EU): by the End of Course 3	-1.87	± 1.118
Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3	-2.27	± 1.314
PF-05280586 (US): by the End of Course 3	-2.34	± 1.036

Change at Course 2/Week 6

Group	Value	95% CI
PF-05280586: by the End of Course 3	-2.62	± 1.172
Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3	-2.74	± 1.552
PF-05280586 (EU): by the End of Course 3	-2.75	± 1.148
Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3	-2.97	± 1.241
PF-05280586 (US): by the End of Course 3	-3.00	± 1.089

Change at Course 2/Week 13

Group	Value	95% CI
PF-05280586: by the End of Course 3	-2.34	± 1.369
Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3	-2.56	± 1.644
PF-05280586 (EU): by the End of Course 3	-2.65	± 1.113
Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3	-2.96	± 1.507
PF-05280586 (US): by the End of Course 3	-3.21	± 1.135

Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 1 Primary · Week 1, 6, 13, and 25 (Course 1).

The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline greater than (\>) 1.2 with present DAS28 less than or equal to (≤) 3.2; moderate responders had a change from baseline \>0.6 and ≤1.2 with present DAS28 ≤3.2 or change from baseline \>0.6 with present DAS28 \>3.2 and ≤5.1 or change from baseline \>1.2 with present DAS28 \>5.1; non-responders had a change from baseline ≤0.6 with present DAS28 ≤5.1 or chan

Course 1/Week 1

Group	Value	95% CI
PF-05280586: by the End of Course 1	13.7
Rituximab-EU: by the End of Course 1	25.0
PF-05280586 (EU): by the End of Course 1	32.3
Rituximab-US: by the End of Course 1	32.0
PF-05280586 (US): by the End of Course 1	21.4

Course 1/Week 6

Group	Value	95% CI
PF-05280586: by the End of Course 1	35.7
Rituximab-EU: by the End of Course 1	54.8
PF-05280586 (EU): by the End of Course 1	46.9
Rituximab-US: by the End of Course 1	43.3
PF-05280586 (US): by the End of Course 1	46.4

Course 1/Week 13

Group	Value	95% CI
PF-05280586: by the End of Course 1	51.8
Rituximab-EU: by the End of Course 1	66.7
PF-05280586 (EU): by the End of Course 1	51.5
Rituximab-US: by the End of Course 1	44.8
PF-05280586 (US): by the End of Course 1	44.8

Course 1/Week 25

Group	Value	95% CI
PF-05280586: by the End of Course 1	57.1
Rituximab-EU: by the End of Course 1	20.0
PF-05280586 (EU): by the End of Course 1	36.4
Rituximab-US: by the End of Course 1	23.1
PF-05280586 (US): by the End of Course 1	36.8

Adverse events — posted to ClinicalTrials.gov

Time frame: Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

PF-05280586: by the End of Course 1

Serious: 4/58 (7%)

Deaths: —

Rituximab-EU: by the End of Course 1

Serious: 2/32 (6%)

Deaths: —

PF-05280586 (EU): by the End of Course 1

Serious: 2/33 (6%)

Deaths: —

Rituximab-US: by the End of Course 1

Serious: 1/30 (3%)

Deaths: —

PF-05280586 (US): by the End of Course 1

Serious: 2/30 (7%)

Deaths: —

PF-05280586: by the End of Course 2

Serious: 6/54 (11%)

Deaths: —

Rituximab-EU/PF-05280586: by the End of Course 2

Serious: 1/30 (3%)

Deaths: —

PF-05280586 (EU): by the End of Course 2

Serious: 4/31 (13%)

Deaths: —

Rituximab-US/PF-05280586: by the End of Course 2

Serious: 2/29 (7%)

Deaths: —

PF-05280586 (US): by the End of Course 2

Serious: 1/29 (3%)

Deaths: —

PF-05280586: by the End of Course 3

Serious: 4/48 (8%)

Deaths: —

Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3

Serious: 1/30 (3%)

Deaths: —

PF-05280586 (EU): by the End of Course 3

Serious: 4/30 (13%)

Deaths: —

Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3

Serious: 1/27 (4%)

Deaths: —

PF-05280586 (US): by the End of Course 3

Serious: 1/29 (3%)

Deaths: —

Serious adverse events (22 terms)

Reaction	System	PF-05280586: by the End of…	Rituximab-EU: by the End o…	PF-05280586 (EU): by the E…	Rituximab-US: by the End o…	PF-05280586 (US): by the E…	PF-05280586: by the End of…	Rituximab-EU/PF-05280586: …	PF-05280586 (EU): by the E…	Rituximab-US/PF-05280586: …	PF-05280586 (US): by the E…	PF-05280586: by the End of…	Rituximab-EU/PF-05280586/P…	PF-05280586 (EU): by the E…	Rituximab-US/PF-05280586/P…	PF-05280586 (US): by the E…
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Febrile Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pericarditis	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Diaphragmatic Hernia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Inguinal Hernia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pancreatitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Umbilical Hernia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Arthritis Infective	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Gastroenteritis Viral	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hydronephrosis	Renal and urinary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Ureterolithiasis	Renal and urinary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Subcutaneous Abscess	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Wound Infection Staphylococcal	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Syncope	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Blighted Ovum	Pregnancy, puerperium and perinatal conditions	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Arthritis Bacterial	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Urinary Tract Infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Transient Ischemic Attack	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (35 terms — click to expand)

Reaction	System	PF-05280586: by the End of…	Rituximab-EU: by the End o…	PF-05280586 (EU): by the E…	Rituximab-US: by the End o…	PF-05280586 (US): by the E…	PF-05280586: by the End of…	Rituximab-EU/PF-05280586: …	PF-05280586 (EU): by the E…	Rituximab-US/PF-05280586: …	PF-05280586 (US): by the E…	PF-05280586: by the End of…	Rituximab-EU/PF-05280586/P…	PF-05280586 (EU): by the E…	Rituximab-US/PF-05280586/P…	PF-05280586 (US): by the E…
Urinary Tract Infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Rheumatoid Arthritis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Upper Respiratory Tract Infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Depression	Psychiatric disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Oedema Peripheral	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Gastrointestinal Viral Infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Foot Fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Back Pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Skin Lesion	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Oral Candidiasis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Neutrophil Count Decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vitamin D Deficiency	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pain In Extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Paraesthesia	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Oral Herpes	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Wrist Fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Alanine Aminotransferase Increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Aspartate Aminotransferase Increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
White Blood Cell Count Decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Pneumonia, Anaemia, Febrile Neutropenia, Pericarditis, Diaphragmatic Hernia, Inguinal Hernia, Pancreatitis, Umbilical Hernia.

Data from ClinicalTrials.gov NCT01643928 adverse events section.

Sponsor's own description

This extension study will evaluate the safety (including immunogenicity) of treatment with rituximab-Pfizer, as well as the safety and immunogenicity after transitioning from rituximab-US or rituximab-EU to rituximab-Pfizer. This study will provide continued treatment access to subjects with active rheumatoid arthritis who have participated for at least 16 weeks in other studies in the rituximab Pfizer program.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Biologics or tofacitinib for people with rheumatoid arthritis naive to methotrexate: a systematic review and network meta-analysis.
Singh JA, Hossain A, Mudano AS, Tanjong Ghogomu E, et al · · 2017 · cited 44× · PMID 28481462 · DOI 10.1002/14651858.cd012657
Biologics or tofacitinib for people with rheumatoid arthritis unsuccessfully treated with biologics: a systematic review and network meta-analysis.
Singh JA, Hossain A, Tanjong Ghogomu E, Mudano AS, et al · · 2017 · cited 38× · PMID 28282491 · DOI 10.1002/14651858.cd012591
Safety outcomes when switching between biosimilars and reference biologics: A systematic review and meta-analysis.
Herndon TM, Ausin C, Brahme NN, Schrieber SJ, et al · · 2023 · cited 37× · PMID 37788264 · DOI 10.1371/journal.pone.0292231
Extension Study of PF-05280586, a Potential Rituximab Biosimilar, Versus Rituximab in Subjects With Active Rheumatoid Arthritis.
Cohen SB, Burgos-Vargas R, Emery P, Jin B, et al · · 2018 · cited 16× · PMID 29692005 · DOI 10.1002/acr.23586
Reply to 'Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers'.
Bakalos G, Schreitmüller T. · · 2017 · cited 2× · PMID 29104764 · DOI 10.1136/esmoopen-2017-000281

Verify or expand the search:

Other recruiting trials for Rheumatoid Arthritis

Currently open trials in the same condition.

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NCT07171983 — A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis · Phase 1 · recruiting
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NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) · Phase 1 · recruiting

Other Pfizer trials

Trials by the same sponsor.

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NCT06507904 — A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or Liquids or With an Anta · Phase 1 · not yet recruiting
NCT06864585 — A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01643928 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 29 January 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01643928.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01643928

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (22 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Rheumatoid Arthritis

Other Pfizer trials

Verify against primary sources