NCT00655824 is a Phase 2 clinical trial of ofatumumab in Arthritis, Rheumatoid, sponsored by GlaxoSmithKline.

Who is sponsoring NCT00655824?

NCT00655824 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT00655824?

Interventions in NCT00655824: ofatumumab.

What condition does NCT00655824 study?

NCT00655824 studies Arthritis, Rheumatoid.

Is NCT00655824 still recruiting?

NCT00655824 is currently terminated. Last updated 5 December 2017.

Are results published for NCT00655824?

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

Last reviewed 2017-12-05 · How we verify

NCT00655824

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

Long-term Efficacy and Safety of Repeated Ofatumumab Treatment Courses in RA Patients Who Previously Received Ofatumumab or Placebo in Trial Hx-CD20-403

Terminated Phase 2 Results posted Last updated 5 December 2017

What this trial tests

Phase 2 trial testing ofatumumab in Arthritis, Rheumatoid in 124 participants. Terminated before completion.

Timeline

1 January 2008

Primary endpoint
25 May 2011

19 March 2013

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	124
Start date	1 January 2008
Primary completion	25 May 2011
Estimated completion	19 March 2013
Sites	10 locations across Denmark, United Kingdom, Poland, Hungary, United States

Drugs / interventions tested

ofatumumab (OFATUMUMAB) — full drug profile →

Conditions studied

Arthritis, Rheumatoid — all drugs for Arthritis, Rheumatoid →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

18 and older, any sex, with Arthritis, Rheumatoid. 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.

Minimum Change From Baseline in Disease Activity Score Based on 28 Joints (DAS28) Over the Course of Weeks (Wk) 1 to 24 in Each Treatment Course (TC), Assessed by Erythrocyte Sedimentation Rate (ESR; Rate at Which Red Blood Cells Sediment in 1 Hour) Secondary · Baseline (last visit prior to dosing in each TC) and last visit of each TC (8 wk post infusion, then every 4 wk until Wk 24; up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.

DAS28(ESR) is a numeric outcome that measures RA activity based on the ESR (a non-specific general indicator of inflammation), tender joint count (JC), swollen JC, and participant's global assessment of disease activity on a 100 millimeter Visual Analog Scale. DAS28 values range from 0 (no activity) and upwards; increasing values indicate increasing activity (there is no upper limit on the scale). Change from baseline (CFB) was calculated at all visits; however, minimum CFB was calculated as the minimum CFB obtained over the course of weeks 1-24 of each treatment cycle.

Treatment Course 1, n=91

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	-1.92	± 0.918

Treatment Course 2, n=71

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	-1.58	± 0.824

Treatment Course 3, n=53

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	-1.52	± 0.849

Treatment Course 4, n=20

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	-1.65	± 1.110

Treatment Course 5, n=8

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	-2.16	± 1.114

Treatment Course 6, n=4

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	-0.87	± 0.771

Treatment Course 7, n=2

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	-2.10	± 2.146

Minimum Change From Baseline in DAS28 Over the Course of Weeks 1 to 24 in Each Treatment Course, Based on C-reactive Protein (CRP) Secondary · Baseline (last visit prior to dosing in each TC) and last visit of each TC (8 wk post infusion, then every 4 wk until Wk 24; up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.

DAS28(CRP) is a numeric outcome that measures RA activity based on the CRP (used to monitor acute inflammatory phases of RA), tender JC, swollen JC, and participant's global assessment of disease activity on a 100 millimeter Visual Analog Scale. DAS28 values range from 0 (no activity) and upwards; increasing values indicate increasing activity (there is no upper limit on the scale). Change from baseline (CFB) was calculated at all visits; however, minimum CFB was calculated as the minimum CFB obtained over the course of weeks 1-24 of each treatment cycle.

Treatment Course 1, n=91

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	-1.79	± 0.906

Treatment Course 2, n=71

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	-1.32	± 0.771

Treatment Course 3, n=53

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	-1.27	± 0.793

Treatment Course 4, n=20

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	-1.55	± 0.970

Treatment Course 5, n=8

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	-1.88	± 1.181

Treatment Course 6, n=4

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	-0.88	± 0.572

Treatment Course 7, n=2

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	-2.14	± 1.893

Time to Re-treatment in Each Treatment Course Secondary · Week 16 to Week 104 of each treatment course (up to 125 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.

Time to re-treatment in each treatment course (TC) is defined as the time from the first infusion of ofatumumab until the date of the first infusion of the first re-treatment course. The data presented reflect the time to re-treatment, which is defined as the time in days between the first infusion of each TC and the first infusion of the following TC. For TC 1, time to re-treatment is defined as the time between the first infusion in TC 1 and the first infusion in TC 2; similarly, for TC 2 it is the time between the first infusion of TC 2 and the first infusion of TC 3. The study was terminat

Treatment Course 1, n=73

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	291.01	± 127.367

Treatment Course 2, n=53

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	328.83	± 122.427

Treatment Course 3, n=20

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	235.95	± 93.924

Treatment Course 4, n=8

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	154.88	± 19.172

Treatment Course 5, n=4

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	161.75	± 22.066

Treatment Course 6, n=2

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	120.00	± 0.000

Ofatumumab Serum Concentration Secondary · Before infusion and at the end of infusion for each Treatment Course (8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next TC; up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial vi

Blood samples of participants were collected for the measurement of ofatumumab concentration in the blood. The blood samples were collected before infusion (BI) (baseline of that particular treatment course) and at the end of infusion (EI) of ofatumumab.

Treatment Course 1, Baseline (BI); n=92

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	3596.3	± 32324.08

Treatment Course 1, Baseline (EI); n=91

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	295588.3	± 67754.65

Treatment Course 1, Week 104; n=1

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	NA	± NA

Treatment Course 2, Baseline (BI); n=73

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	837.6	± 3102.94

Treatment Course 2, Baseline (EI); n=92

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	292283.5	± 87672.90

Treatment Course 2, Week 80; n=1

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	NA	± NA

Treatment Course 3, Baseline (BI); n=53

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	955.0	± 3270.64

Treatment Course 3, Baseline (EI); n=53

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	276719.3	± 68620.07

Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood Secondary · Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.

Blood samples of participants were collected for the evaluation of CD19+, CD4+, CD3+, and CD8+ B-cell subsets. These biomarkers are associated with immune functions.

CD19+, Treatment Course 1, Baseline; n=92

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	6.4	± 4.45

CD19+, Treatment Course 1, Week 104; n=1

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	4.0	± NA

CD19+, Treatment Course 2, Baseline; n=72

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	1.9	± 3.06

CD19+, Treatment Course 2, Week 80; n=1

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	2.0	± NA

CD19+, Treatment Course 3, Baseline; n=53

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	2.6	± 2.99

CD19+, Treatment Course 3, Week 64; n=1

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	1.0	± NA

CD19+, Treatment Course 4, Baseline; n=20

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	1.7	± 2.68

CD19+, Treatment Course 4, Week 40; n=1

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	3.0	± NA

CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 Secondary · Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.

Blood samples of participants were collected for the evaluation of CD19+, CD4+, CD3+, and CD8+ cell counts. These cells are present on white blood cells and are used as markers to associate cells with immune functions.

CD19+, Treatment Course 1, Baseline; n=92

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	109.6	± 91.12

CD19+, Treatment Course 1, Week 104; n=1

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	95.0	± NA

CD19+, Treatment Course 2, Baseline; n=71

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	30.0	± 49.36

CD19+, Treatment Course 2, Week 80; n=1

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	24.0	± NA

CD19+, Treatment Course 3, Baseline; n=51

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	43.8	± 50.11

CD19+, Treatment Course 3, Week 64; n=1

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	16.0	± NA

CD19+, Treatment Course 4, Baseline; n=20

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	27.2	± 43.75

CD19+, Treatment Course 4, Week 40; n=1

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	54.0	± NA

Ratio of CD 4+/CD8+ Secondary · Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.

Blood samples of participants were collected for the evaluation of CD4+ and CD8+ cell counts and the ratio was calculated.

Treatment Course 1, Baseline; n=72

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	2.55	± 1.295

Treatment Course 1, Week 48; n=1

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	5.40	± NA

Treatment Course 2, Week 24; n=1

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	4.10	± NA

Treatment Course 2, Week 56; n=1

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	2.60	± NA

Treatment Course 3, Baseline; n=1

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	2.60	± NA

Treatment Course 3, Week 32; n=2

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	2.40	± 0.424

Treatment Course 4, Baseline; n=1

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	1.50	± NA

Number of Participants With Rheumatoid Factor (RA Factor) >13 International Units Per Milliliter Secondary · Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.

Blood samples of participants were collected for the evaulation of RA factor. RA factor is an antibody found in the blood of participants with rheumatoid arthritis and is used for the diagnosis of rheumatoid arthritis.

Treatment Course 1, Baseline; n=92

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	79

Treatment Course 1, Week 104; n=1

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	1

Treatment Course 1, At any time; n=92

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	81

Treatment Course 2, Baseline; n=73

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	60

Treatment Course 2, Week 80; n=1

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	1

Treatment Course 2, At any time; n=73

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	63

Treatment Course 3, Baseline; n=53

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	42

Treatment Course 3, Week 64; n=1

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	1

Number of Participants With Anti-cyclic Citrullinated Peptide Antibody (CCP) >6.9 International Units Per Liter Secondary · Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.

Blood samples of participants were collected for the evaluation of Anti-CCP. Anti-CCP plays an important role in immune response and helps assess the disease condition.

Treatment Course 1, Baseline; n=92

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	80

Treatment Course 1, Week 104; n=1

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	1

Treatment Course 1, At any time; n=92

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	83

Treatment Course 2, Baseline; n=73

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	66

Treatment Course 2, Week 80; n=1

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	1

Treatment Course 2, At any time; n=73

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	67

Treatment Course 3, Baseline; n=53

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	48

Treatment Course 3, Week 64; n=1

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	1

Number of Participants With B-Lymphocyte Stimulator (BLyS) >2.49 Micrograms Per Liter Secondary · Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.

Blood samples of participants were collected for the evaluation of BLyS. BLyS is a potent co-stimulator of B lymphocytes, and elevated levels of BLyS are observed in automimmune diseases. It regulates the immunnoglobin (antibody produced by B cells that is used by the immune system to indentify bacteria and viruses in the body) secretion of normal B cells (type of cells in the blood).

Treatment Course 1, Baseline; n=92

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	12

Treatment Course 1, Week 104; n=1

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	0

Treatment Course 1, At any time; n=92

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	81

Treatment Course 2, Baseline; n=73

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	38

Treatment Course 2, Week 80; n=1

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	0

Treatment Course 2, At any time; n=73

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	65

Treatment Course 3, Baseline; n=53

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	32

Treatment Course 3, Week 64; n=1

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	1

Number of Participants With Interleukin 6 (IL-6) >11.9 Picograms Per Milliliter Secondary · Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.

Blood samples of participants were collected for the evaluation of IL-6. IL-6 plays an important role in immune response and helps assess the disease condition.

Treatment Course 1, Baseline; n=92

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	40

Treatment Course 1, Week 104; n=1

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	0

Treatment Course 1, At any time; n=92

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	47

Treatment Course 2, Baseline; n=73

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	12

Treatment Course 2, Week 80; n=1

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	1

Treatment Course 2, At any time; n=73

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	27

Treatment Course 3, Baseline; n=52

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	11

Treatment Course 3, Week 64; n=1

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	0

Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid Secondary · Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.

Blood samples of participants were collected for the evaluation of uric acid and electrolytes (sodium, potassium, chloride, and calcium), as increased levels may reflect B-cell lysis due to treatment with ofatumumab.

Sodium, Treatment Course 1, Baseline; n=92

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	142.1	± 2.76

Sodium, Treatment Course 1, Week 104; n=1

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	144.0	± NA

Sodium, Treatment Course 2, Baseline; n=73

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	142.3	± 2.25

Sodium, Treatment Course 2, Week 80; n=1

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	145.0	± NA

Sodium, Treatment Course 3, Baseline; n=53

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	143.3	± 2.26

Sodium, Treatment Course 3, Week 64; n=1

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	147.0	± NA

Sodium, Treatment Course 4, Baseline; n=20

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	142.8	± 2.65

Sodium, Treatment Course 4, Week 40; n=1

Group	Value	95% CI
Ofatumumab 700 mg IV Infusion	145.0	± NA

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Ofatumumab 700 mg IV Infusion

Serious: 11/92 (12%)

Deaths: —

Serious adverse events (16 terms)

Reaction	System	Ofatumumab 700 mg IV Infus…
Memory impairment	Nervous system disorders	—
Amnesia	Nervous system disorders	—
Aphasia	Nervous system disorders	—
Cholecystitis	Hepatobiliary disorders	—
Cholelithiasis	Hepatobiliary disorders	—
Disturbance in attention	Nervous system disorders	—
Fall	Injury, poisoning and procedural complications	—
Hypertension	Vascular disorders	—
Joint dislocation	Injury, poisoning and procedural complications	—
Myocardial infarction	Cardiac disorders	—
Osteitis	Musculoskeletal and connective tissue disorders	—
Pancreatitis	Gastrointestinal disorders	—
Pneumonia	Infections and infestations	—
Rash	Skin and subcutaneous tissue disorders	—
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	—
Visual impairment	Eye disorders	—

Other adverse events (158 terms — click to expand)

Reaction	System	Ofatumumab 700 mg IV Infus…
Rash	Skin and subcutaneous tissue disorders	—
Upper respiratory tract infection	Infections and infestations	—
Cough	Respiratory, thoracic and mediastinal disorders	—
Throat irritation	Respiratory, thoracic and mediastinal disorders	—
Headache	Nervous system disorders	—
Sneezing	Respiratory, thoracic and mediastinal disorders	—
Rhinitis	Infections and infestations	—
Urinary tract infection	Infections and infestations	—
Urticaria	Skin and subcutaneous tissue disorders	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—
Neutropenia	Blood and lymphatic system disorders	—
Bronchitis	Infections and infestations	—
Nasopharyngitis	Infections and infestations	—
Oral herpes	Infections and infestations	—
Leukopenia	Blood and lymphatic system disorders	—
Hypertension	Vascular disorders	—
Fatigue	General disorders	—
Influenza	Infections and infestations	—
Pharyngitis	Infections and infestations	—
Respiratory tract infection	Infections and infestations	—
Sinusitis	Infections and infestations	—
Pruritus	Skin and subcutaneous tissue disorders	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—
Aphasia	Nervous system disorders	—
Memory impairment	Nervous system disorders	—
Nausea	Gastrointestinal disorders	—
Hepatic enzyme Increased	Investigations	—
Anemia	Blood and lymphatic system disorders	—
Conjunctivitis	Eye disorders	—
Dry eye	Eye disorders	—
Flushing	Vascular disorders	—
Vertigo	Ear and labyrinth disorders	—
Abscess	Infections and infestations	—
Cystitis	Infections and infestations	—
Lower respiratory tract infection	Infections and infestations	—
Alopecia	Skin and subcutaneous tissue disorders	—
Rash generalized	Skin and subcutaneous tissue disorders	—
Dry throat	Respiratory, thoracic and mediastinal disorders	—
Throat tightness	Respiratory, thoracic and mediastinal disorders	—
Back pain	Musculoskeletal and connective tissue disorders	—

Most-reported serious reactions: Memory impairment, Amnesia, Aphasia, Cholecystitis, Cholelithiasis, Disturbance in attention, Fall, Hypertension.

Data from ClinicalTrials.gov NCT00655824 adverse events section.

Sponsor's own description

A 3-year open-label trial for patients who previously participated in Trial Hx-CD20-403 and who fulfill the eligibility criteria for this trial (GEN413) . Th e primary purpose of the trial is to evaluate the long-term effectiveness of repeated courses ( a maximum of 9 treatment courses) of ofatumumab in RA patients who previously received ofatumumab or placebo in Trial Hx-CD20-403.

Publications & conference data

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

Next-generation anti-CD20 monoclonal antibodies in autoimmune disease treatment.
Du FH, Mills EA, Mao-Draayer Y. · · 2017 · cited 120× · PMID 29143151 · DOI 10.1007/s13317-017-0100-y
B-cell targeted therapeutics in clinical development.
Blüml S, McKeever K, Ettinger R, Smolen J, et al · · 2013 · cited 74× · PMID 23566679 · DOI 10.1186/ar3906
Ofatumumab.
Zhang B. · · 2009 · cited 55× · PMID 20068404 · DOI 10.4161/mabs.1.4.8895
Clinical Perspectives on the Molecular and Pharmacological Attributes of Anti-CD20 Therapies for Multiple Sclerosis.
Bar-Or A, O'Brien SM, Sweeney ML, Fox EJ, et al · · 2021 · cited 37× · PMID 34370283 · DOI 10.1007/s40263-021-00843-8
Safety of Repeated Open-Label Treatment Courses of Intravenous Ofatumumab, a Human Anti-CD20 Monoclonal Antibody, in Rheumatoid Arthritis: Results from Three Clinical Trials.
Quattrocchi E, Østergaard M, Taylor PC, van Vollenhoven RF, et al · · 2016 · cited 15× · PMID 27336685 · DOI 10.1371/journal.pone.0157961

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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 NCT00655824 (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 GlaxoSmithKline
Last refreshed: 5 December 2017

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/NCT00655824.

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

NCT00655824

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 (16 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of ofatumumab

Other recruiting trials for Arthritis, Rheumatoid

Other GlaxoSmithKline trials

Verify against primary sources