NCT02969044 is a Phase 2 clinical trial of PF-06651600 in Rheumatoid Arthritis, sponsored by Pfizer.

Who is sponsoring NCT02969044?

NCT02969044 is sponsored by Pfizer.

What drugs are being tested in NCT02969044?

Interventions in NCT02969044: Placebo, PF-06651600.

What condition does NCT02969044 study?

NCT02969044 studies Rheumatoid Arthritis.

Is NCT02969044 still recruiting?

NCT02969044 is currently completed. Last updated 4 December 2018.

Are results published for NCT02969044?

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

Last reviewed 2018-12-04 · How we verify

NCT02969044

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

Study To Assess The Efficacy And Safety Of Pf-06651600 In Subjects With Rheumatoid Arthritis With An Inadequate Response To Methotrexate

Completed Phase 2 Results posted Last updated 4 December 2018

What this trial tests

Phase 2 trial testing Placebo in Rheumatoid Arthritis in 70 participants. Completed in 12 December 2017.

Timeline

20 December 2016

Primary endpoint
12 December 2017

12 December 2017

Quick facts

Lead sponsor	Pfizer
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	70
Start date	20 December 2016
Primary completion	12 December 2017
Estimated completion	12 December 2017
Sites	30 locations across Georgia, Slovakia, Serbia, Germany, Hungary, Poland, Bulgaria, United States

Drugs / interventions tested

Placebo
PF-06651600 (pf-06651600) — 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 Simple Disease Activity Index (SDAI) Score at Week 8 Primary · Baseline, Week 8

The SDAI is the numerical sum of five outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on a visual analogue scale (VAS) scale ranging from 0 to 10 centimeter (cm), where higher scores=greater affection due to disease activity, and C-reactive protein (CRP) measured in terms of milligram per deciliter (mg/dL). SDAI total score= 0 to 86. SDAI greater than or equal to (\<=) 3.3 indicates disease remission, greater than (\>) 3.4 to 11 = low disease activity, \>11

Baseline

Group	Value	95% CI
PF-06651600	45.15	± 13.164
Placebo	44.85	± 13.976

Change at Week 8

Group	Value	95% CI
PF-06651600	-26.11	± 14.834
Placebo	-17.38	± 18.176

Number of Participants With Vital Signs Abnormalities Secondary · Baseline up to Week 12

Criteria: sitting pulse rate less than (\<) 40 beats per minute (bpm) or \>120 bpm; sitting systolic blood pressure (SBP) \>=30 millimeters of mercury (mmHg) change from baseline in same posture or \<90 mmHg; diastolic blood pressure (DBP) \>=20 mmHg change from baseline in same posture or \<50 mmHg. Only those categories in which at least one participant had abnormality, were reported in this outcome measure.

Sitting DBP >=20 mmHg increase from baseline

Group	Value	95% CI
PF-06651600	3
Placebo	0

Sitting DBP >=20 mmHg decrease from baseline

Group	Value	95% CI
PF-06651600	0
Placebo	1

Number of Participants With Laboratory Abnormalities Secondary · Baseline up to Week 12

Hemoglobin(Hb);hematocrit;RBC count:\<0.8\*lower limit of normal (LLN),mean corpuscular volume;mean corpuscular Hb concentration:\<0.9\*LLN or\>1.1\*upper limit of normal (ULN), platelet:\<0.5\*LLN or \>1.75\*ULN,reticulocytes \<0.5\*LLN or \>1.5\*ULN,leukocytes \<0.6\*LLN or \>1.5\*ULN,lymphocyte;neutrophil: \<0.8\*LLN or \>1.2\*ULN,basophil;eosinophil; monocyte:\>1.2\*ULN,partial thromboplastin time,prothrombin time\>1.1\*ULN,bilirubin\>1.5\*ULN, aspartate aminotransferase; alanine aminotransferase;alkaline phosphatase:\>3.0\*ULN,protein;albumin;LDL, HDL cholesterol:\<0.8\*LLN or \>1.2\*ULN;

Group	Value	95% CI
PF-06651600	42
Placebo	28

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Secondary · Baseline up to Week 12

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 12 that were absent before treatment or that worsened relative to pretreatment state.

AEs

Group	Value	95% CI
PF-06651600	20
Placebo	5

SAEs

Group	Value	95% CI
PF-06651600	0
Placebo	0

Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 1, 2, 4 and 6 Secondary · Baseline, Week 1, 2, 4 and 6

The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on a VAS scale ranging from 0 to 10 cm, where higher scores=greater affection due to disease activity, and CRP measured in terms of mg/dL. SDAI total score= 0 to 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.

Change at Week 1

Group	Value	95% CI
PF-06651600	-4.59	± 9.409
Placebo	-4.52	± 7.025

Change at Week 2

Group	Value	95% CI
PF-06651600	-12.82	± 10.969
Placebo	-8.05	± 9.402

Change at Week 4

Group	Value	95% CI
PF-06651600	-17.79	± 12.804
Placebo	-12.55	± 13.462

Change at Week 6

Group	Value	95% CI
PF-06651600	-22.79	± 14.007
Placebo	-15.62	± 14.231

Remission Rate Based on Simple Disease Activity Index Score Secondary · Week 4, 6 and 8

Remission rate was defined as percentage of participants with disease remission. The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on a VAS scale ranging from 0 to 10 cm, where higher scores=greater affection due to disease activity, and CRP measured in terms of mg/dL. SDAI total score= 0 to 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.

Week 4

Group	Value	95% CI
PF-06651600	4.8
Placebo	0.0

Week 6

Group	Value	95% CI
PF-06651600	4.8
Placebo	0.0

Week 8

Group	Value	95% CI
PF-06651600	7.1
Placebo	0.0

Remission Rate Based on Disease Activity Score (DAS28-3 [ESR]) Secondary · Week 4, 6 and 8

Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, and erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hr\]). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) \<2.6 = remission.

Week 4

Group	Value	95% CI
PF-06651600	4.8
Placebo	0.0

Week 6

Group	Value	95% CI
PF-06651600	2.4
Placebo	0.0

Week 8

Group	Value	95% CI
PF-06651600	7.1
Placebo	0.0

Remission Rate Based on Disease Activity Score (DAS28-4[ESR]) Secondary · Week 4, 6 and 8

Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from the number of SJC and TJC using the 28 joints count, the ESR (mm/hour) and participant's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease acti

Week 4

Group	Value	95% CI
PF-06651600	4.8
Placebo	0.0

Week 6

Group	Value	95% CI
PF-06651600	4.8
Placebo	0.0

Week 8

Group	Value	95% CI
PF-06651600	7.1
Placebo	0.0

Remission Rate Based on Disease Activity Score (DAS28-3 [CRP]) Secondary · Week 4, 6 and 8

Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) \<2.6 = remission.

Week 4

Group	Value	95% CI
PF-06651600	9.5
Placebo	0.0

Week 6

Group	Value	95% CI
PF-06651600	7.1
Placebo	3.6

Week 8

Group	Value	95% CI
PF-06651600	9.5
Placebo	0.0

Remission Rate Based on Disease Activity Score (DAS28-4 [CRP]) Secondary · Week 4, 6 and 8

Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP): calculated from SJC, TJC, CRP (mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) \<2.6=remission, \<3.2=low disease activity, \>=3.2-5.1=moderate disease activity and \>5.1=high disease activity.

Week 4

Group	Value	95% CI
PF-06651600	9.5
Placebo	0.0

Week 6

Group	Value	95% CI
PF-06651600	9.5
Placebo	3.6

Week 8

Group	Value	95% CI
PF-06651600	9.5
Placebo	0.0

Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) at Week 1, 2, 4, 6 and 8 Secondary · Baseline, Week 1, 2, 4, 6 and 8

DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, and ESR (mm/hr). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) \<2.6 = remission.

Baseline

Group	Value	95% CI
PF-06651600	6.49	± 0.762
Placebo	6.37	± 0.815

Change at Week 1

Group	Value	95% CI
PF-06651600	-0.19	± 0.604
Placebo	-0.26	± 0.434

Change at Week 2

Group	Value	95% CI
PF-06651600	-0.67	± 0.602
Placebo	-0.46	± 0.531

Change at Week 4

Group	Value	95% CI
PF-06651600	-1.16	± 1.125
Placebo	-0.78	± 0.905

Change at Week 6

Group	Value	95% CI
PF-06651600	-1.54	± 1.123
Placebo	-1.07	± 0.989

Change at Week 8

Group	Value	95% CI
PF-06651600	-1.85	± 1.161
Placebo	-1.07	± 1.214

Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 1, 2, 4, 6 and 8 Secondary · Baseline, Week 1, 2, 4, 6 and 8

DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = remission.

Baseline

Group	Value	95% CI
PF-06651600	6.82	± 0.815
Placebo	6.72	± 0.880

Change at Week 1

Group	Value	95% CI
PF-06651600	-0.27	± 0.553
Placebo	-0.27	± 0.477

Change at Week 2

Group	Value	95% CI
PF-06651600	-0.83	± 0.695
Placebo	-0.47	± 0.551

Change at Week 4

Group	Value	95% CI
PF-06651600	-1.36	± 1.173
Placebo	-0.89	± 0.951

Change at Week 6

Group	Value	95% CI
PF-06651600	-1.81	± 1.179
Placebo	-1.18	± 1.050

Change at Week 8

Group	Value	95% CI
PF-06651600	-2.14	± 1.269
Placebo	-1.22	± 1.448

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline up to Week 12. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

PF-06651600

Serious: 0/42 (0%)

Deaths: 0/42

Placebo

Serious: 0/28 (0%)

Deaths: 0/28

Other adverse events (28 terms — click to expand)

Reaction	System	PF-06651600	Placebo
Lymphopenia	Blood and lymphatic system disorders	—	—
Influenza	Infections and infestations	—	—
Headache	Nervous system disorders	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—
Abdominal distension	Gastrointestinal disorders	—	—
Glossitis	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Fatigue	General disorders	—	—
Oedema peripheral	General disorders	—	—
Hepatotoxicity	Hepatobiliary disorders	—	—
Asymptomatic bacteriuria	Infections and infestations	—	—
Fungal skin infection	Infections and infestations	—	—
Oral herpes	Infections and infestations	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Fall	Injury, poisoning and procedural complications	—	—
Ligament sprain	Injury, poisoning and procedural complications	—	—
Alanine aminotransferase increased	Investigations	—	—
Aspartate aminotransferase increased	Investigations	—	—
Blood creatine phosphokinase increased	Investigations	—	—
Cytomegalovirus test positive	Investigations	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Spinal pain	Musculoskeletal and connective tissue disorders	—	—
Synovitis	Musculoskeletal and connective tissue disorders	—	—
Suicidal ideation	Psychiatric disorders	—	—
Acne	Skin and subcutaneous tissue disorders	—	—
Dermatitis	Skin and subcutaneous tissue disorders	—	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—	—

Data from ClinicalTrials.gov NCT02969044 adverse events section.

Sponsor's own description

This is an 8 week study to assess the efficacy and safety profile of PF-06651600 in seropositive subjects with rheumatoid arthritis with an inadequate response to methotrexate (up to approximately 50% of subjects may also have had an inadequate response to 1 anti-TNF biologic).

Publications & conference data

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

Janus kinase-targeting therapies in rheumatology: a mechanisms-based approach.
Tanaka Y, Luo Y, O'Shea JJ, Nakayamada S. · · 2022 · cited 329× · PMID 34987201 · DOI 10.1038/s41584-021-00726-8
JAK inhibition as a therapeutic strategy for immune and inflammatory diseases.
Schwartz DM, Kanno Y, Villarino A, Ward M, et al · · 2017 · cited 308× · PMID 29282366 · DOI 10.1038/nrd.2017.267
STAT proteins: a kaleidoscope of canonical and non-canonical functions in immunity and cancer.
Awasthi N, Liongue C, Ward AC. · · 2021 · cited 97× · PMID 34809691 · DOI 10.1186/s13045-021-01214-y
JAK-STAT signaling in human disease: From genetic syndromes to clinical inhibition.
Luo Y, Alexander M, Gadina M, O'Shea JJ, et al · · 2021 · cited 92× · PMID 34625141 · DOI 10.1016/j.jaci.2021.08.004
The Role of Janus Kinase Signaling in Graft-Versus-Host Disease and Graft Versus Leukemia.
Schroeder MA, Choi J, Staser K, DiPersio JF. · · 2018 · cited 82× · PMID 29289756 · DOI 10.1016/j.bbmt.2017.12.797
Janus kinase inhibitors for the treatment of rheumatoid arthritis demonstrate similar profiles of in vitro cytokine receptor inhibition.
Dowty ME, Lin TH, Jesson MI, Hegen M, et al · · 2019 · cited 76× · PMID 31832202 · DOI 10.1002/prp2.537
The new entries in the therapeutic armamentarium: The small molecule JAK inhibitors.
Bechman K, Yates M, Galloway JB. · · 2019 · cited 64× · PMID 31401212 · DOI 10.1016/j.phrs.2019.104392
Therapeutic Implication of SOCS1 Modulation in the Treatment of Autoimmunity and Cancer.
Sharma J, Larkin J. · · 2019 · cited 62× · PMID 31105556 · DOI 10.3389/fphar.2019.00324

Verify or expand the search:

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Currently open trials in the same condition.

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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 NCT02969044 (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: 4 December 2018

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/NCT02969044.

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

NCT02969044

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of PF-06651600

Other recruiting trials for Rheumatoid Arthritis

Other Pfizer trials

Verify against primary sources