NCT02996500 is a Phase 2 clinical trial of PF-06650833 in Rheumatoid Arthritis, sponsored by Pfizer.

Who is sponsoring NCT02996500?

NCT02996500 is sponsored by Pfizer.

What drugs are being tested in NCT02996500?

Interventions in NCT02996500: PF-06650833, Placebo, Tofacitinib.

What condition does NCT02996500 study?

NCT02996500 studies Rheumatoid Arthritis.

Is NCT02996500 still recruiting?

NCT02996500 is currently completed. Last updated 27 February 2020.

Are results published for NCT02996500?

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

Last reviewed 2020-02-27 · How we verify

NCT02996500

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

Safety and Efficacy of Pf-06650833 In Subjects With Rheumatoid Arthritis, With An Inadequate Response To Methotrexate

Completed Phase 2 Results posted Last updated 27 February 2020

What this trial tests

Phase 2 trial testing PF-06650833 in Rheumatoid Arthritis in 269 participants. Completed in 15 August 2018.

Timeline

10 November 2016

Primary endpoint
15 August 2018

15 August 2018

Quick facts

Lead sponsor	Pfizer
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	269
Start date	10 November 2016
Primary completion	15 August 2018
Estimated completion	15 August 2018
Sites	103 locations across Taiwan, Poland, South Korea, Croatia, Russia, Mexico, Bulgaria, United States

Drugs / interventions tested

PF-06650833 — full drug profile →
Placebo
Tofacitinib (tofacitinib) — full drug profile →

Conditions studied

Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

Pfizer — full company profile →

Who can join

Adults 18 to 75, 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.

Change From Baseline in the Simplified Disease Activity Index (SDAI) at Week 12 Primary · Baseline and Week 12

The SDAI is a continuous composite measure derived from components of the American College of Rheumatology (ACR) Core Dataset.The SDAI was calculated using the following formula: SDAI = Tender / Painful Joint Count(TJC) (using 28 joints) + Swollen Joint Count (SJC) (using 28 joints) + Patient Global Assessment of Arthritis (PtGA) (0-10 cm scale) + Physician's Global Assessment of Arthritis (PhGA) (0-10 cm scale) + high sensitivity C-reactive protein (hsCRP) (mg/dL). SDAI total score= 0-86. SDAI \<=3.3 indicates disease remission, \>3.4 to 11 = low disease activity, \>11 to 26 = moderate diseas

Group	Value	95% CI
Placebo	-13.87	-17.70 – -10.02
PF-06650833 20 mg	-21.71	-26.14 – -17.20
PF-06650833 60 mg	-22.83	-26.57 – -19.20
PF-06650833 200 mg	-24.77	-28.54 – -21.08
PF-06650833 400 mg	-25.16	-28.85 – -21.39

Change From Baseline in SDAI at Weeks 4 and 8 Secondary · Baseline, Weeks 4 and 8

The SDAI is a continuous composite measure derived from components of the American College of Rheumatology (ACR) Core Dataset.The SDAI was calculated using the following formula: SDAI = TJC (using 28 joints) + SJC (using 28 joints) + PtGA (0-10 cm scale) + PhGA (0-10 cm scale) + hsCRP (mg/dL). SDAI total score= 0-86. SDAI \<=3.3 indicates disease remission, \>3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high disease activity. The descriptive summary of change from baseline in SDAI was based on a mixed effect model repeat measurement MMRM model with obser

Week 4

Group	Value	95% CI
Placebo	-10.78	-15.07 – -6.49
PF-06650833 20 mg	-12.39	-14.68 – -10.10
PF-06650833 60 mg	-14.29	-16.87 – -11.71
PF-06650833 200 mg	-13.56	-17.25 – -9.86
PF-06650833 400 mg	-12.30	-15.46 – -9.14

Week 8

Group	Value	95% CI
Placebo	-17.07	-22.58 – -11.55
PF-06650833 20 mg	-16.62	-20.71 – -12.53
PF-06650833 60 mg	-18.85	-22.03 – -15.67
PF-06650833 200 mg	-19.95	-24.81 – -15.08
PF-06650833 400 mg	-21.15	-25.50 – -16.79

Percentage of Participants With SDAI Low Disease Activity Score (LDAS) (SDAI <=11) at 4, 8, and 12 Weeks Secondary · Weeks 4, 8 and 12

The SDAI is a continuous composite measure derived from components of the American College of Rheumatology (ACR) Core Dataset.The SDAI was calculated using the following formula: SDAI = TJC (using 28 joints) + SJC (using 28 joints) + PtGA (0-10 cm scale) + PhGA (0-10 cm scale) + hsCRP (mg/dL). The criterion of SDAI LDAS was SDAI\<=11. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.

Week 4

Group	Value	95% CI
Placebo	8.1	0.0 – 16.9
PF-06650833 20 mg	7.9	0.0 – 16.5
PF-06650833 60 mg	12.2	3.1 – 21.4
PF-06650833 200 mg	10.6	1.8 – 19.5
PF-06650833 400 mg	8.5	0.5 – 16.5

Week 8

Group	Value	95% CI
Placebo	14.7	2.8 – 26.6
PF-06650833 20 mg	20.0	6.7 – 33.3
PF-06650833 60 mg	17.4	6.4 – 28.3
PF-06650833 200 mg	29.3	15.3 – 43.2
PF-06650833 400 mg	33.3	19.6 – 47.1

Week 12

Group	Value	95% CI
Placebo	26.5	11.6 – 41.3
PF-06650833 20 mg	41.9	24.6 – 59.3
PF-06650833 60 mg	28.9	15.6 – 42.1
PF-06650833 200 mg	38.6	24.2 – 53.0
PF-06650833 400 mg	42.2	27.8 – 56.7

Percentage of Participants With SDAI Remission (SDAI <=3.3) at 4, 8, and 12 Weeks Secondary · Weeks 4, 8 and 12

The SDAI is a continuous composite measure derived from components of the American College of Rheumatology (ACR) Core Dataset.The SDAI was calculated using the following formula: SDAI = TJC (using 28 joints) + SJC (using 28 joints) + PtGA (0-10 cm scale) + PhGA (0-10 cm scale) + hsCRP (mg/dL). The criterion of SDAI remission was SDAI\<=3.3. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.

Week 4

Group	Value	95% CI
Placebo	0	0.0 – 0.0
PF-06650833 20 mg	2.6	0.0 – 7.7
PF-06650833 60 mg	2.0	0.0 – 6.0
PF-06650833 200 mg	0	0.0 – 0.0
PF-06650833 400 mg	2.1	0.0 – 6.3

Week 8

Group	Value	95% CI
Placebo	0	0.0 – 0.0
PF-06650833 20 mg	8.6	0.0 – 17.8
PF-06650833 60 mg	0	0.0 – 0.0
PF-06650833 200 mg	7.3	0.0 – 15.3
PF-06650833 400 mg	2.2	0.0 – 6.5

Week 12

Group	Value	95% CI
Placebo	2.9	0.0 – 8.6
PF-06650833 20 mg	3.2	0.0 – 9.4
PF-06650833 60 mg	2.2	0.0 – 6.5
PF-06650833 200 mg	6.8	0.0 – 14.3
PF-06650833 400 mg	8.9	0.6 – 17.2

Percentage of Participants With Disease Activity Score-28 (4 Components Based on Erythrocyte Sedimentation Rate) (DAS28-4 [ESR]) LDAS (DAS28 <3.2) at 4, 8, and 12 Weeks Secondary · Weeks 4, 8 and 12

The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (ESR) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, ESR and PGA. DAS28-4 (ESR) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.70 ln(ESR \[mm/first hour\] + 0.014 (PtGA \[mm\]). Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-4 (ESR) LDAS was DAS28\<3.2. Tofacitinib was included in this stu

Week 4

Group	Value	95% CI
Placebo	2.9	0.0 – 8.4
PF-06650833 20 mg	8.1	0.0 – 16.9
PF-06650833 60 mg	6.4	0.0 – 13.4
PF-06650833 200 mg	8.3	0.5 – 16.2
PF-06650833 400 mg	4.3	0.0 – 10.0

Week 8

Group	Value	95% CI
Placebo	8.6	0.0 – 17.8
PF-06650833 20 mg	17.1	4.7 – 29.6
PF-06650833 60 mg	13.6	3.5 – 23.8
PF-06650833 200 mg	13.3	3.4 – 23.3
PF-06650833 400 mg	12.8	3.2 – 22.3

Week 12

Group	Value	95% CI
Placebo	17.6	4.8 – 30.5
PF-06650833 20 mg	20.0	5.7 – 34.3
PF-06650833 60 mg	24.4	11.9 – 37.0
PF-06650833 200 mg	22.2	10.1 – 34.4
PF-06650833 400 mg	17.8	6.6 – 28.9

Percentage of Participants With DAS28-3 (ESR) LDAS (DAS28 <3.2) at 4, 8, and 12 Weeks Secondary · Weeks 4, 8 and 12

The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-3 (ESR) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed and ESR. DAS28-3 (ESR) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.70 ln(ESR \[mm/first hour\]\*1.08+0.16. Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-3 LDAS was DAS28\<3.2. Tofacitinib was included in this study as an active contro

Week 4

Group	Value	95% CI
Placebo	5.7	0.0 – 13.4
PF-06650833 20 mg	8.1	0.0 – 16.9
PF-06650833 60 mg	10.6	1.8 – 19.5
PF-06650833 200 mg	8.3	0.5 – 16.2
PF-06650833 400 mg	4.3	0.0 – 10.0

Week 8

Group	Value	95% CI
Placebo	8.6	0.0 – 17.8
PF-06650833 20 mg	20.0	6.7 – 33.3
PF-06650833 60 mg	15.9	5.1 – 26.7
PF-06650833 200 mg	8.9	0.6 – 17.2
PF-06650833 400 mg	14.9	4.7 – 25.1

Week 12

Group	Value	95% CI
Placebo	20.6	7.0 – 34.2
PF-06650833 20 mg	20.0	5.7 – 34.3
PF-06650833 60 mg	22.2	10.1 – 34.4
PF-06650833 200 mg	22.2	10.1 – 34.4
PF-06650833 400 mg	15.6	5.0 – 26.1

Percentage of Participants With Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]) LDAS (DAS28 <3.2) at 4, 8, and 12 Weeks Secondary · Weeks 4, 8 and 12

The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, hs-CRP and PtGA. DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP \[mg/L\] +1) + 0.014 (PtGA \[mm\]) + 0.96. Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-4 LDAS was DAS28\<3.2. Tofacitinib was included in this stu

Week 4

Group	Value	95% CI
Placebo	8.1	0.0 – 16.9
PF-06650833 20 mg	13.2	2.4 – 23.9
PF-06650833 60 mg	16.3	6.0 – 26.7
PF-06650833 200 mg	12.8	3.2 – 22.3
PF-06650833 400 mg	8.5	0.5 – 16.5

Week 8

Group	Value	95% CI
Placebo	11.8	0.9 – 22.6
PF-06650833 20 mg	20.0	6.7 – 33.3
PF-06650833 60 mg	19.6	8.1 – 31.0
PF-06650833 200 mg	26.8	13.3 – 40.4
PF-06650833 400 mg	33.3	19.6 – 47.1

Week 12

Group	Value	95% CI
Placebo	20.6	7.0 – 34.2
PF-06650833 20 mg	38.7	21.6 – 55.9
PF-06650833 60 mg	35.6	21.6 – 49.5
PF-06650833 200 mg	40.9	26.4 – 55.4
PF-06650833 400 mg	42.2	27.8 – 56.7

Percentage of Participants With DAS28-3 (CRP) LDAS (DAS28 <3.2) at 4, 8, and 12 Weeks Secondary · Weeks 4, 8 and 12

The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-3 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed and hs-CRP. DAS28-3 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP \[mg/L\] +1)\*1.10+ 1.15. Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-3 LDAS was DAS28\<3.2. Tofacitinib was included in this study as an active control

Week 4

Group	Value	95% CI
Placebo	8.1	0.0 – 16.9
PF-06650833 20 mg	10.5	0.8 – 20.3
PF-06650833 60 mg	16.3	6.0 – 26.7
PF-06650833 200 mg	17.0	6.3 – 27.8
PF-06650833 400 mg	10.6	1.8 – 19.5

Week 8

Group	Value	95% CI
Placebo	20.6	7.0 – 34.2
PF-06650833 20 mg	22.9	8.9 – 36.8
PF-06650833 60 mg	19.6	8.1 – 31.0
PF-06650833 200 mg	34.1	19.6 – 48.7
PF-06650833 400 mg	37.8	23.6 – 51.9

Week 12

Group	Value	95% CI
Placebo	23.5	9.3 – 37.8
PF-06650833 20 mg	41.9	24.6 – 59.3
PF-06650833 60 mg	40.0	25.7 – 54.3
PF-06650833 200 mg	47.7	33.0 – 62.5
PF-06650833 400 mg	42.2	27.8 – 56.7

Percentage of Participants With DAS28-4 (ESR) Remission (DAS28 <2.6) at 4, 8 and 12 Weeks Secondary · Weeks 4, 8 and 12

The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (ESR) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, ESR and PtGA. DAS28-4 (ESR) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.70 ln(ESR \[mm/first hour\] + 0.014 (PtGA \[mm\]). Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-4 remission was DAS28\<2.6. Tofacitinib was included in this stu

Week 4

Group	Value	95% CI
Placebo	0	0.0 – 0.0
PF-06650833 20 mg	5.4	0.0 – 12.7
PF-06650833 60 mg	2.1	0.0 – 6.3
PF-06650833 200 mg	8.3	0.5 – 16.2
PF-06650833 400 mg	2.1	0.0 – 6.3

Week 8

Group	Value	95% CI
Placebo	5.7	0.0 – 13.4
PF-06650833 20 mg	11.4	0.9 – 22.0
PF-06650833 60 mg	9.1	0.6 – 17.6
PF-06650833 200 mg	6.7	0.0 – 14.0
PF-06650833 400 mg	10.6	1.8 – 19.5

Week 12

Group	Value	95% CI
Placebo	5.9	0.0 – 13.8
PF-06650833 20 mg	16.7	3.3 – 30.0
PF-06650833 60 mg	13.3	3.4 – 23.3
PF-06650833 200 mg	8.9	0.6 – 17.2
PF-06650833 400 mg	11.1	1.9 – 20.3

Percentage of Participants With DAS28-3 (ESR) Remission (DAS28 <2.6) at 4, 8 and 12 Weeks Secondary · Weeks 4, 8 and 12

The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-3 (ESR) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed and ESR. DAS28-3 (ESR) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.70 ln(ESR \[mm/first hour\]\*1.08+0.16. Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-3 remission was DAS28\<2.6. Tofacitinib was included in this study as an active c

Week 4

Group	Value	95% CI
Placebo	0	0.0 – 0.0
PF-06650833 20 mg	2.7	0.0 – 7.9
PF-06650833 60 mg	2.1	0.0 – 6.3
PF-06650833 200 mg	6.3	0.0 – 13.1
PF-06650833 400 mg	2.1	0.0 – 6.3

Week 8

Group	Value	95% CI
Placebo	2.9	0.0 – 8.4
PF-06650833 20 mg	8.6	0.0 – 17.8
PF-06650833 60 mg	9.1	0.6 – 17.6
PF-06650833 200 mg	6.7	0.0 – 14.0
PF-06650833 400 mg	8.5	0.5 – 16.5

Week 12

Group	Value	95% CI
Placebo	8.8	0.0 – 18.4
PF-06650833 20 mg	10.0	0.0 – 20.7
PF-06650833 60 mg	13.3	3.4 – 23.3
PF-06650833 200 mg	11.1	1.9 – 20.3
PF-06650833 400 mg	8.9	0.6 – 17.2

Percentage of Participants With DAS28-4 (CRP) Remission (DAS28 <2.6) at 4, 8 and 12 Weeks Secondary · Weeks 4, 8 and 12

The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, hs-CRP and PtGA. DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP \[mg/L\] +1) + 0.014 (PtGA \[mm\]) + 0.96. Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-4 remission was DAS28\<2.6. Tofacitinib was included in thi

Week 4

Group	Value	95% CI
Placebo	2.7	0.0 – 7.9
PF-06650833 20 mg	5.3	0.0 – 12.4
PF-06650833 60 mg	8.2	0.5 – 15.8
PF-06650833 200 mg	10.6	1.8 – 19.5
PF-06650833 400 mg	6.4	0.0 – 13.4

Week 8

Group	Value	95% CI
Placebo	8.8	0.0 – 18.4
PF-06650833 20 mg	17.1	4.7 – 29.6
PF-06650833 60 mg	10.9	1.9 – 19.9
PF-06650833 200 mg	22.0	9.3 – 34.6
PF-06650833 400 mg	13.3	3.4 – 23.3

Week 12

Group	Value	95% CI
Placebo	14.7	2.8 – 26.6
PF-06650833 20 mg	22.6	7.9 – 37.3
PF-06650833 60 mg	17.8	6.6 – 28.9
PF-06650833 200 mg	25.0	12.2 – 37.8
PF-06650833 400 mg	24.4	11.9 – 37.0

Percentage of Participants With DAS28-3 (CRP) Remission (DAS28 <2.6) at 4, 8 and 12 Weeks Secondary · Weeks 4, 8 and 12

The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-3 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed and hs-CRP. DAS28-3 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP \[mg/L\] +1)\*1.10+1.15. Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-3 remission was DAS28\<2.6. Tofacitinib was included in this study as an active con

Week 4

Group	Value	95% CI
Placebo	5.4	0.0 – 12.7
PF-06650833 20 mg	5.3	0.0 – 12.4
PF-06650833 60 mg	10.2	1.7 – 18.7
PF-06650833 200 mg	8.5	0.5 – 16.5
PF-06650833 400 mg	4.3	0.0 – 10.0

Week 8

Group	Value	95% CI
Placebo	8.8	0.0 – 18.4
PF-06650833 20 mg	14.3	2.7 – 25.9
PF-06650833 60 mg	10.9	1.9 – 19.9
PF-06650833 200 mg	22.0	9.3 – 34.6
PF-06650833 400 mg	13.3	3.4 – 23.3

Week 12

Group	Value	95% CI
Placebo	11.8	0.9 – 22.6
PF-06650833 20 mg	25.8	10.4 – 41.2
PF-06650833 60 mg	22.2	10.1 – 34.4
PF-06650833 200 mg	22.7	10.3 – 35.1
PF-06650833 400 mg	22.2	10.1 – 34.4

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 1/39 (3%)

Deaths: 0/39

Tofa 10 mg

Serious: 1/43 (2%)

Deaths: 0/43

PF-06650833 20 mg

Serious: 1/39 (3%)

Deaths: 0/39

PF-06650833 60 mg

Serious: 1/50 (2%)

Deaths: 0/50

PF-06650833 200 mg

Serious: 1/50 (2%)

Deaths: 0/50

PF-06650833 400 mg

Serious: 3/48 (6%)

Deaths: 0/48

Serious adverse events (10 terms)

Reaction	System	Placebo	Tofa 10 mg	PF-06650833 20 mg	PF-06650833 60 mg	PF-06650833 200 mg	PF-06650833 400 mg
Acute myocardial infarction	Cardiac disorders	—	—	—	—	—	—
Hepatotoxicity	Hepatobiliary disorders	—	—	—	—	—	—
Abscess limb	Infections and infestations	—	—	—	—	—	—
Appendicitis	Infections and infestations	—	—	—	—	—	—
Epididymitis	Infections and infestations	—	—	—	—	—	—
Pneumonia bacterial	Infections and infestations	—	—	—	—	—	—
Humerus fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—
Subdural haematoma	Injury, poisoning and procedural complications	—	—	—	—	—	—
Cerebral haematoma	Nervous system disorders	—	—	—	—	—	—
Haemothorax	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—

Other adverse events (8 terms — click to expand)

Reaction	System	Placebo	Tofa 10 mg	PF-06650833 20 mg	PF-06650833 60 mg	PF-06650833 200 mg	PF-06650833 400 mg
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—
Abdominal Pain	Gastrointestinal disorders	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—

Most-reported serious reactions: Acute myocardial infarction, Hepatotoxicity, Abscess limb, Appendicitis, Epididymitis, Pneumonia bacterial, Humerus fracture, Subdural haematoma.

Data from ClinicalTrials.gov NCT02996500 adverse events section.

Sponsor's own description

This is a Phase 2, multicenter, randomized, double blind, double dummy, placebo and active-controlled, parallel group study to assess the efficacy and safety of PF 06650833 at Week 12 in subjects with moderate-severe, active, RA who have had an inadequate response to MTX. PF-06650833 or matching placebo tablets will be administered orally QD under fasting conditions, and tofacitinib or matching tofacitinib placebo tablets will be administered orally BID for 12 weeks in a blinded fashion.

Publications & conference data

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

Toll-like receptor signalling in B cells during systemic lupus erythematosus.
Fillatreau S, Manfroi B, Dörner T. · · 2021 · cited 229× · PMID 33339987 · DOI 10.1038/s41584-020-00544-4
The central role of inflammatory signaling in the pathogenesis of myelodysplastic syndromes.
Sallman DA, List A. · · 2019 · cited 202× · PMID 30670444 · DOI 10.1182/blood-2018-10-844654
Small Molecule NF-κB Pathway Inhibitors in Clinic.
Ramadass V, Vaiyapuri T, Tergaonkar V. · · 2020 · cited 154× · PMID 32708302 · DOI 10.3390/ijms21145164
Innate immune pathways and inflammation in hematopoietic aging, clonal hematopoiesis, and MDS.
Trowbridge JJ, Starczynowski DT. · · 2021 · cited 153× · PMID 34129017 · DOI 10.1084/jem.20201544
Plasmacytoid dendritic cell biology and its role in immune-mediated diseases.
Ye Y, Gaugler B, Mohty M, Malard F. · · 2020 · cited 107× · PMID 32489664 · DOI 10.1002/cti2.1139
Inhibition of interleukin-1 receptor-associated kinase 1 (IRAK1) as a therapeutic strategy.
Singer JW, Fleischman A, Al-Fayoumi S, Mascarenhas JO, et al · · 2018 · cited 105× · PMID 30279971 · DOI 10.18632/oncotarget.26058
The role of inflammation in autoimmune disease: a therapeutic target.
Xiang Y, Zhang M, Jiang D, Su Q, et al · · 2023 · cited 104× · PMID 37859999 · DOI 10.3389/fimmu.2023.1267091
Synovial fibroblasts as potential drug targets in rheumatoid arthritis, where do we stand and where shall we go?
Németh T, Nagy G, Pap T. · · 2022 · cited 86× · PMID 35715191 · DOI 10.1136/annrheumdis-2021-222021

Verify or expand the search:

Other trials of PF-06650833

Trials testing the same drug.

NCT05064332 — A Study To Estimate The Effect of PF-06650833 On The Pharmacokinetics (PK) of Oral Contraceptive (OC) · Phase 1 · completed
NCT04933799 — IRAK 4 Inhibitor (PF-06650833) in Hospitalized Patients With COVID-19 Pneumonia and Exuberant Inflammation. · Phase 2 · unknown
NCT04575610 — IRAK4 Inhibition in Treatment of COVID-19 With ARDS (I-RAMIC) · Phase 2 · terminated
NCT04413617 — TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS · Phase 2 · completed
NCT04092452 — A Study to Evaluate the Safety and Efficacy of PF-06650833, PF-06700841, and PF 06826647 in Adults With Hidradenitis Sup · Phase 2 · completed

Other recruiting trials for Rheumatoid Arthritis

Currently open trials in the same condition.

NCT07433335 — A Study to Assess the Safety and Tolerability of SR-878 in Patients With Rheumatoid Arthritis · Phase 1 · recruiting
NCT07491016 — Efficacy and Safety of Telitacicept Combined With Baricitinib for Refractory Rheumatoid Arthritis · recruiting
NCT07171983 — A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis · Phase 1 · recruiting
NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel · EARLY_PHASE1 · recruiting
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.

NCT04982848 — Korea Post Marketing Surveillance (PMS) Study of Talzenna® · not yet recruiting
NCT06873191 — A Study to Learn More About Tukysa Once it is Out in the Korean Market · not yet recruiting
NCT07497854 — A Study to Learn About the Study Medicine NURTEC® ODT 75 mg After it is Released Into the Markets in Korea · not yet recruiting
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 NCT02996500 (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: 27 February 2020

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/NCT02996500.

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

NCT02996500

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 (10 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of PF-06650833

Other recruiting trials for Rheumatoid Arthritis

Other Pfizer trials

Verify against primary sources