NCT04413617 is a Phase 2 clinical trial of PF-06650833 in Rheumatoid Arthritis, sponsored by Pfizer.

Who is sponsoring NCT04413617?

NCT04413617 is sponsored by Pfizer.

What drugs are being tested in NCT04413617?

Interventions in NCT04413617: PF-06650833, PF-06651600, Tofacitinib.

What condition does NCT04413617 study?

NCT04413617 studies Rheumatoid Arthritis.

Is NCT04413617 still recruiting?

NCT04413617 is currently completed. Last updated 7 April 2023.

Are results published for NCT04413617?

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

Last reviewed 2023-04-07 · How we verify

NCT04413617

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

TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE

Completed Phase 2 Results posted Last updated 7 April 2023

What this trial tests

Phase 2 trial testing PF-06650833 in Rheumatoid Arthritis in 460 participants. Completed in 7 February 2022.

Timeline

29 July 2020

Primary endpoint
7 February 2022

7 February 2022

Quick facts

Lead sponsor	Pfizer
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	460
Start date	29 July 2020
Primary completion	7 February 2022
Estimated completion	7 February 2022
Sites	144 locations across Georgia, Slovakia, Ukraine, Chile, Hungary, Poland, Canada, Bulgaria

Drugs / interventions tested

PF-06650833 — full drug profile →
PF-06651600 (pf-06651600) — full drug profile →
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 70, 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 (BL) in Disease Activity Score (DAS)28-C Reactive Protein (CRP) at Week 12 Primary · BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12

DAS28 is a measure based on assessment of 28 joints for tenderness and swelling (tender and swollen joint counts). Disease Activity Score 28-C reactive protein (DAS28-CRP) is derived using differential weighting given to 4 components: tender joint count (range: 0-28), swollen joint count (range: 0-28), patient global assessment (recorded on a visual analog scale \[VAS\] scale of 0-100 mm), and CRP (milligram per liter). DAS28-CRP score ranges from 0 to 9.4. The lower the DAS28-CRP score is, the better the participant has response (remission = score\<2.6, low disease activity = score≤3.2). A ne

Group	Value	95% CI
PF-06650833 400mg MR + Tofacitinib 11mg MR	-2.65	-2.84 – -2.46
PF-06650833 400mg MR + PF-06651600 100mg	-2.35	-2.54 – -2.15
Tofacitinib 11mg MR	-2.30	-2.49 – -2.11
PF-06651600 100mg	-2.20	-2.43 – -1.98
PF-06650833 400mg MR	-1.82	-2.04 – -1.60

DAS28-CRP Remission (<2.6) Rates at Week 24 Secondary · Week 24

DAS28-CRP is derived using differential weighting given to 4 components: tender joint count, swollen joint count, patient global assessment, and CRP. Remission is defined as DAS28-CRP score \<2.6. Remission rate = the number of responders (who had remission) / (number of responders + non-responders + non-responder assigned by non-responder imputation \[NRI\] after removal of missingness due to COVID-19 and missing components at a given visit)

Group	Value	95% CI
PF-06650833 400mg MR + Tofacitinib 11mg MR	40.8	32.6 – 48.7
PF-06650833 400mg MR + PF-06651600 100mg	31.3	24.1 – 39.8
Tofacitinib 11mg MR	24.0	17.1 – 31.8
PF-06651600 100mg	22.4	14.8 – 31.3
PF-06650833 400mg MR	11.8	6.7 – 19.3

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs), and Withdrawals Due to TEAEs Secondary · From first dose of study intervention (Day 1) to Week 28

An adverse event (AE) was any untoward medical occurrence in a patient or clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE (SAE) was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; or other serious situations such as important medical events. TEAEs were events between firs

All-causality TEAEs

Group	Value	95% CI
Tofacitinib 11mg MR	60
PF-06651600 100mg	42
PF-06650833 400mg MR	38
PF-06650833 400mg MR + Tofacitinib 11mg MR	51
PF-06650833 400mg MR + PF-06651600 100mg	55

Treatment-related TEAEs

Group	Value	95% CI
Tofacitinib 11mg MR	15
PF-06651600 100mg	17
PF-06650833 400mg MR	13
PF-06650833 400mg MR + Tofacitinib 11mg MR	20
PF-06650833 400mg MR + PF-06651600 100mg	25

All-causality TESAEs

Group	Value	95% CI
Tofacitinib 11mg MR	3
PF-06651600 100mg	3
PF-06650833 400mg MR	3
PF-06650833 400mg MR + Tofacitinib 11mg MR	0
PF-06650833 400mg MR + PF-06651600 100mg	1

Treatment-related TESAEs

Group	Value	95% CI
Tofacitinib 11mg MR	0
PF-06651600 100mg	0
PF-06650833 400mg MR	0
PF-06650833 400mg MR + Tofacitinib 11mg MR	0
PF-06650833 400mg MR + PF-06651600 100mg	0

Discontinuation from study due to all-causality TEAEs

Group	Value	95% CI
Tofacitinib 11mg MR	2
PF-06651600 100mg	0
PF-06650833 400mg MR	0
PF-06650833 400mg MR + Tofacitinib 11mg MR	1
PF-06650833 400mg MR + PF-06651600 100mg	1

Discontinuation from study due to treatment-related TEAEs

Group	Value	95% CI
Tofacitinib 11mg MR	1
PF-06651600 100mg	0
PF-06650833 400mg MR	0
PF-06650833 400mg MR + Tofacitinib 11mg MR	1
PF-06650833 400mg MR + PF-06651600 100mg	0

Study drug withdrawal due to all-causality TEAEs but continued study

Group	Value	95% CI
Tofacitinib 11mg MR	0
PF-06651600 100mg	6
PF-06650833 400mg MR	6
PF-06650833 400mg MR + Tofacitinib 11mg MR	4
PF-06650833 400mg MR + PF-06651600 100mg	6

Study drug withdrawal due to treatment-related TEAEs but continued study

Group	Value	95% CI
Tofacitinib 11mg MR	0
PF-06651600 100mg	4
PF-06650833 400mg MR	4
PF-06650833 400mg MR + Tofacitinib 11mg MR	3
PF-06650833 400mg MR + PF-06651600 100mg	4

Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) Secondary · From BL to Week 28

Clinical laboratory abnormality was determined at the investigator's discretion.

Hematology: Hemoglobin (gram per deciliter [g/dL]) <0.8x lower limit of normal (LLN)

Group	Value	95% CI
Tofacitinib 11mg MR	2
PF-06651600 100mg	2
PF-06650833 400mg MR	0
PF-06650833 400mg MR + Tofacitinib 11mg MR	2
PF-06650833 400mg MR + PF-06651600 100mg	2

Erythrocytes (10^6/millimeter^3 [10^6/mm^3]) <0.8x LLN

Group	Value	95% CI
Tofacitinib 11mg MR	0
PF-06651600 100mg	2
PF-06650833 400mg MR	0
PF-06650833 400mg MR + Tofacitinib 11mg MR	0
PF-06650833 400mg MR + PF-06651600 100mg	0

Erythrocyte (Ery.) Mean Corpuscular Volume (micrometer^3 [um^3]) <0.9x LLN

Group	Value	95% CI
Tofacitinib 11mg MR	3
PF-06651600 100mg	2
PF-06650833 400mg MR	0
PF-06650833 400mg MR + Tofacitinib 11mg MR	2
PF-06650833 400mg MR + PF-06651600 100mg	0

Ery. Mean Corpuscular Volume (um^3) >1.1x upper limit of normal (ULN)

Group	Value	95% CI
Tofacitinib 11mg MR	4
PF-06651600 100mg	3
PF-06650833 400mg MR	4
PF-06650833 400mg MR + Tofacitinib 11mg MR	3
PF-06650833 400mg MR + PF-06651600 100mg	4

Ery. Mean Corpuscular Hemoglobin (picogram/cell [pg/cell]) <0.9x LLN

Group	Value	95% CI
Tofacitinib 11mg MR	8
PF-06651600 100mg	5
PF-06650833 400mg MR	3
PF-06650833 400mg MR + Tofacitinib 11mg MR	7
PF-06650833 400mg MR + PF-06651600 100mg	4

Ery. Mean Corpuscular Hemoglobin (HGB) Concentration (g/dL) <0.9x LLN

Group	Value	95% CI
Tofacitinib 11mg MR	8
PF-06651600 100mg	6
PF-06650833 400mg MR	12
PF-06650833 400mg MR + Tofacitinib 11mg MR	10
PF-06650833 400mg MR + PF-06651600 100mg	4

Platelets (10^3/mm^3) >1.75xULN

Group	Value	95% CI
Tofacitinib 11mg MR	0
PF-06651600 100mg	0
PF-06650833 400mg MR	0
PF-06650833 400mg MR + Tofacitinib 11mg MR	1
PF-06650833 400mg MR + PF-06651600 100mg	0

Reticulocytes/Erythrocytes (%) >1.5x ULN

Group	Value	95% CI
Tofacitinib 11mg MR	2
PF-06651600 100mg	1
PF-06650833 400mg MR	2
PF-06650833 400mg MR + Tofacitinib 11mg MR	1
PF-06650833 400mg MR + PF-06651600 100mg	1

Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria Secondary · From BL to Week 28

Abnormality in change from BL in vital signs included: sitting/semi-supine diastolic blood pressure (BP) increase and decrease from BL of \>=20mmHg, systolic BP increase and decrease from BL of \>=30mmHg

Diastolic BP increase >=20mmHg

Group	Value	95% CI
Tofacitinib 11mg MR	1
PF-06651600 100mg	2
PF-06650833 400mg MR	3
PF-06650833 400mg MR + Tofacitinib 11mg MR	6
PF-06650833 400mg MR + PF-06651600 100mg	3

Diastolic BP decrease >=20mmHg

Group	Value	95% CI
Tofacitinib 11mg MR	0
PF-06651600 100mg	0
PF-06650833 400mg MR	0
PF-06650833 400mg MR + Tofacitinib 11mg MR	0
PF-06650833 400mg MR + PF-06651600 100mg	0

Systolic BP increase >=30mmHg

Group	Value	95% CI
Tofacitinib 11mg MR	1
PF-06651600 100mg	3
PF-06650833 400mg MR	4
PF-06650833 400mg MR + Tofacitinib 11mg MR	2
PF-06650833 400mg MR + PF-06651600 100mg	3

Systolic BP decrease >=30mmHg

Group	Value	95% CI
Tofacitinib 11mg MR	0
PF-06651600 100mg	0
PF-06650833 400mg MR	0
PF-06650833 400mg MR + Tofacitinib 11mg MR	0
PF-06650833 400mg MR + PF-06651600 100mg	0

Number of Participants With Adverse Events of Special Interest Secondary · From first dose of study intervention (Day 1) to Week 28

These AEs included severe and opportunistic infection AEs; herpes virus infection AEs; clinically significant categorical increases in hepatic enzymes AST, and ALT and total bilirubin, and potential cases meeting Hy's Law criteria for increased risk of drug induced liver injury (DILI); major adverse cardiovascular events, including pulmonary embolism and deep vein thrombosis, cerebrovascular accident; AEs for decreased renal function, acute kidney injury, clinically significant increases in serum creatinine (Scr) and decreases in estimated glomerular filtration rate (eGFR). Only participants w

Herpes Zoster

Group	Value	95% CI
Tofacitinib 11mg MR	1
PF-06651600 100mg	1
PF-06650833 400mg MR	0
PF-06650833 400mg MR + Tofacitinib 11mg MR	2
PF-06650833 400mg MR + PF-06651600 100mg	0

Oral Herpes

Group	Value	95% CI
Tofacitinib 11mg MR	1
PF-06651600 100mg	0
PF-06650833 400mg MR	0
PF-06650833 400mg MR + Tofacitinib 11mg MR	1
PF-06650833 400mg MR + PF-06651600 100mg	2

ALT Increased

Group	Value	95% CI
Tofacitinib 11mg MR	0
PF-06651600 100mg	0
PF-06650833 400mg MR	3
PF-06650833 400mg MR + Tofacitinib 11mg MR	2
PF-06650833 400mg MR + PF-06651600 100mg	0

AST Increased

Group	Value	95% CI
Tofacitinib 11mg MR	0
PF-06651600 100mg	0
PF-06650833 400mg MR	2
PF-06650833 400mg MR + Tofacitinib 11mg MR	2
PF-06650833 400mg MR + PF-06651600 100mg	0

Hyperbilirubinaemia

Group	Value	95% CI
Tofacitinib 11mg MR	1
PF-06651600 100mg	0
PF-06650833 400mg MR	0
PF-06650833 400mg MR + Tofacitinib 11mg MR	0
PF-06650833 400mg MR + PF-06651600 100mg	0

Transaminases Increased

Group	Value	95% CI
Tofacitinib 11mg MR	0
PF-06651600 100mg	0
PF-06650833 400mg MR	1
PF-06650833 400mg MR + Tofacitinib 11mg MR	0
PF-06650833 400mg MR + PF-06651600 100mg	0

Hepatic Enzyme Increased

Group	Value	95% CI
Tofacitinib 11mg MR	0
PF-06651600 100mg	0
PF-06650833 400mg MR	1
PF-06650833 400mg MR + Tofacitinib 11mg MR	0
PF-06650833 400mg MR + PF-06651600 100mg	0

Liver Injury

Group	Value	95% CI
Tofacitinib 11mg MR	0
PF-06651600 100mg	0
PF-06650833 400mg MR	1
PF-06650833 400mg MR + Tofacitinib 11mg MR	0
PF-06650833 400mg MR + PF-06651600 100mg	0

Change From Baseline in DAS28-CRP at Week 24 Secondary · BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 24

DAS28 is a measure based on assessment of 28 joints for tenderness and swelling (tender and swollen joint counts). DAS28-CRP is derived using differential weighting given to 4 components: tender joint count (range: 0-28), swollen joint count (range: 0-28), patient global assessment (recorded on a visual analog scale \[VAS\] scale of 0-100 mm), and CRP (milligram per liter). DAS28-CRP score ranges from 0 to 9.4. The lower the DAS28-CRP score is, the better the participant has response (remission = score\<2.6, low disease activity = score≤3.2). A negative value in change from BL indicates an imp

Group	Value	95% CI
PF-06650833 400mg MR + Tofacitinib 11mg MR	-3.05	-3.26 – -2.85
PF-06650833 400mg MR + PF-06651600 100mg	-2.87	-3.08 – -2.65
Tofacitinib 11mg MR	-2.66	-2.88 – -2.45
PF-06651600 100mg	-2.53	-2.78 – -2.28
PF-06650833 400mg MR	-2.26	-2.51 – -2.00

American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24 Secondary · BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12, Week 24

The American College of Rheumatology's definition for calculating improvement in rheumatoid arthritis (ACR20) is calculated as a \>=20% improvement in tender and swollen joint counts and 20% improvement in 3 of the 5 remaining ACR core set measures: patient and physician global assessments, pain, disability, and CRP. Similarly, ACR50, ACR70, and ACR 90 were calculated with the respective percent improvement. Responder rate = number of responders (who had ACR20/50/70/90 response)/(number of responders + non-responders + non-responder assigned by non-responder imputation \[NRI\] after removal of

ACR20 (Week 12)

Group	Value	95% CI
PF-06650833 400mg MR + Tofacitinib 11mg MR	86.41	79.94 – 91.59
PF-06650833 400mg MR + PF-06651600 100mg	79.21	71.99 – 85.62
Tofacitinib 11mg MR	83.17	75.94 – 88.98
PF-06651600 100mg	72.73	63.80 – 80.94
PF-06650833 400mg MR	75.00	66.26 – 82.24

ACR50 (Week 12)

Group	Value	95% CI
PF-06650833 400mg MR + Tofacitinib 11mg MR	62.75	54.69 – 70.75
PF-06650833 400mg MR + PF-06651600 100mg	54.46	45.79 – 62.57
Tofacitinib 11mg MR	46.53	38.04 – 55.19
PF-06651600 100mg	44.16	34.59 – 54.16
PF-06650833 400mg MR	38.16	29.16 – 47.81

ACR70 (Week 12)

Group	Value	95% CI
PF-06650833 400mg MR + Tofacitinib 11mg MR	21.36	15.35 – 28.95
PF-06650833 400mg MR + PF-06651600 100mg	25.74	19.17 – 33.29
Tofacitinib 11mg MR	23.76	16.96 – 31.42
PF-06651600 100mg	18.18	11.34 – 26.08
PF-06650833 400mg MR	10.53	5.39 – 18.17

ACR90 (Week 12)

Group	Value	95% CI
PF-06650833 400mg MR + Tofacitinib 11mg MR	2.91	1.07 – 6.86
PF-06650833 400mg MR + PF-06651600 100mg	3.96	1.74 – 8.58
Tofacitinib 11mg MR	0.99	0.10 – 4.12
PF-06651600 100mg	1.30	0.14 – 5.32
PF-06650833 400mg MR	1.32	0.14 – 5.39

ACR20 (Week 24)

Group	Value	95% CI
PF-06650833 400mg MR + Tofacitinib 11mg MR	75.73	68.31 – 82.41
PF-06650833 400mg MR + PF-06651600 100mg	70.00	61.87 – 77.31
Tofacitinib 11mg MR	75.25	67.64 – 82.11
PF-06651600 100mg	67.53	57.99 – 76.32
PF-06650833 400mg MR	55.26	45.20 – 65.01

ACR50 (Week 24)

Group	Value	95% CI
PF-06650833 400mg MR + Tofacitinib 11mg MR	65.05	57.08 – 72.34
PF-06650833 400mg MR + PF-06651600 100mg	65.00	56.68 – 72.92
Tofacitinib 11mg MR	65.35	57.14 – 73.21
PF-06651600 100mg	54.55	44.56 – 63.80
PF-06650833 400mg MR	43.42	33.74 – 53.50

ACR70 (Week 24)

Group	Value	95% CI
PF-06650833 400mg MR + Tofacitinib 11mg MR	45.63	37.25 – 54.20
PF-06650833 400mg MR + PF-06651600 100mg	44.00	35.61 – 52.72
Tofacitinib 11mg MR	44.55	36.60 – 53.22
PF-06651600 100mg	31.17	22.51 – 40.74
PF-06650833 400mg MR	27.63	19.32 – 36.52

ACR90 (Week 24)

Group	Value	95% CI
PF-06650833 400mg MR + Tofacitinib 11mg MR	12.62	8.05 – 19.19
PF-06650833 400mg MR + PF-06651600 100mg	18.00	12.27 – 25.23
Tofacitinib 11mg MR	9.90	5.58 – 16.09
PF-06651600 100mg	5.19	2.28 – 11.34
PF-06650833 400mg MR	1.32	0.14 – 5.39

Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 Secondary · BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12, Week 24

The endpoint included Tender/Painful Joint Count 68 (TJC68) and 28 (TJC28). TJC68 was assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful in upper body and upper/lower extremity. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). The 28-joints set is the subset of 68 joints set including the following joints: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees. TJC28 was c

TJC28 (Week 12)

Group	Value	95% CI
PF-06650833 400mg MR + Tofacitinib 11mg MR	-9.87	-10.65 – -9.09
PF-06650833 400mg MR + PF-06651600 100mg	-9.78	-10.58 – -8.98
Tofacitinib 11mg MR	-9.84	-10.63 – -9.05
PF-06651600 100mg	-9.83	-10.76 – -8.91
PF-06650833 400mg MR	-8.82	-9.73 – -7.92

TJC68 (Week 12)

Group	Value	95% CI
PF-06650833 400mg MR + Tofacitinib 11mg MR	-14.96	-16.09 – -13.83
PF-06650833 400mg MR + PF-06651600 100mg	-15.66	-16.81 – -14.50
Tofacitinib 11mg MR	-15.32	-16.47 – -14.18
PF-06651600 100mg	-14.80	-16.13 – -13.46
PF-06650833 400mg MR	-13.76	-15.07 – -12.46

SJC28 (Week 12)

Group	Value	95% CI
PF-06650833 400mg MR + Tofacitinib 11mg MR	-8.61	-9.16 – -8.06
PF-06650833 400mg MR + PF-06651600 100mg	-8.16	-8.73 – -7.60
Tofacitinib 11mg MR	-7.86	-8.41 – -7.30
PF-06651600 100mg	-8.30	-8.95 – -7.65
PF-06650833 400mg MR	-7.80	-8.44 – -7.15

SJC66 (Week 12)

Group	Value	95% CI
PF-06650833 400mg MR + Tofacitinib 11mg MR	-11.29	-11.99 – -10.59
PF-06650833 400mg MR + PF-06651600 100mg	-10.90	-11.62 – -10.19
Tofacitinib 11mg MR	-10.34	-11.05 – -9.63
PF-06651600 100mg	-10.75	-11.58 – -9.92
PF-06650833 400mg MR	-10.18	-11.00 – -9.37

TJC28 (Week 24)

Group	Value	95% CI
PF-06650833 400mg MR + Tofacitinib 11mg MR	-11.33	-12.06 – -10.61
PF-06650833 400mg MR + PF-06651600 100mg	-11.44	-12.20 – -10.68
Tofacitinib 11mg MR	-10.60	-11.34 – -9.86
PF-06651600 100mg	-10.47	-11.34 – -9.59
PF-06650833 400mg MR	-10.31	-11.20 – -9.42

TJC68 (Week 24)

Group	Value	95% CI
PF-06650833 400mg MR + Tofacitinib 11mg MR	-16.68	-17.78 – -15.57
PF-06650833 400mg MR + PF-06651600 100mg	-17.68	-18.82 – -16.53
Tofacitinib 11mg MR	-16.76	-17.88 – -15.64
PF-06651600 100mg	-16.69	-18.02 – -15.36
PF-06650833 400mg MR	-15.79	-17.13 – -14.46

SJC28 (Week 24)

Group	Value	95% CI
PF-06650833 400mg MR + Tofacitinib 11mg MR	-8.83	-9.34 – -8.31
PF-06650833 400mg MR + PF-06651600 100mg	-9.44	-9.98 – -8.90
Tofacitinib 11mg MR	-8.76	-9.29 – -8.24
PF-06651600 100mg	-8.71	-9.33 – -8.08
PF-06650833 400mg MR	-8.28	-8.92 – -7.65

SJC66 (Week 24)

Group	Value	95% CI
PF-06650833 400mg MR + Tofacitinib 11mg MR	-11.41	-12.02 – -10.80
PF-06650833 400mg MR + PF-06651600 100mg	-12.38	-13.03 – -11.74
Tofacitinib 11mg MR	-11.59	-12.21 – -10.97
PF-06651600 100mg	-11.45	-12.19 – -10.71
PF-06650833 400mg MR	-11.10	-11.86 – -10.34

Change From Baseline in the Physician's Global Assessment (PhGA) of Arthritis at Week 12 and Week 24 Secondary · BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12, Week 24

PhGA of Arthritis is an evaluation done by investigator based on the participant's disease signs, functional capacity and physical examination, and should be independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS. Physician's Global Assessment score ranges from 0 to 100. Higher scores indicate higher level of disability. A negative value in change from BL indicates an improvement.

PhGA of Arthritis (Week 12)

Group	Value	95% CI
PF-06650833 400mg MR + Tofacitinib 11mg MR	-43.50	-46.32 – -40.69
PF-06650833 400mg MR + PF-06651600 100mg	-41.20	-44.06 – -38.34
Tofacitinib 11mg MR	-40.86	-43.72 – -38.00
PF-06651600 100mg	-38.62	-41.95 – -35.28
PF-06650833 400mg MR	-31.56	-34.82 – -28.30

PhGA of Arthritis (Week 24)

Group	Value	95% CI
PF-06650833 400mg MR + Tofacitinib 11mg MR	-47.50	-50.13 – -44.87
PF-06650833 400mg MR + PF-06651600 100mg	-48.21	-50.95 – -45.47
Tofacitinib 11mg MR	-47.31	-49.98 – -44.63
PF-06651600 100mg	-43.42	-46.60 – -40.25
PF-06650833 400mg MR	-39.27	-42.49 – -36.05

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose of study intervention (Day 1) to Week 28. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Tofacitinib 11mg MR

Serious: 3/102 (3%)

Deaths: 1/102

PF-06651600 100mg

Serious: 3/77 (4%)

Deaths: 0/77

PF-06650833 400mg MR

Serious: 3/77 (4%)

Deaths: 0/77

PF-06650833 400mg MR + Tofacitinib 11mg MR

Serious: 0/103 (0%)

Deaths: 0/103

PF-06650833 400mg MR + PF-06651600 100mg

Serious: 1/101 (1%)

Deaths: 0/101

Serious adverse events (10 terms)

Reaction	System	Tofacitinib 11mg MR	PF-06651600 100mg	PF-06650833 400mg MR	PF-06650833 400mg MR + Tof…	PF-06650833 400mg MR + PF-…
COVID-19 pneumonia	Infections and infestations	—	—	—	—	—
Coronavirus infection	Infections and infestations	—	—	—	—	—
Femur fracture	Injury, poisoning and procedural complications	—	—	—	—	—
Diabetic ketoacidosis	Metabolism and nutrition disorders	—	—	—	—	—
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Skin squamous cell carcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—
Renal colic	Renal and urinary disorders	—	—	—	—	—
Endometrial hyperplasia	Reproductive system and breast disorders	—	—	—	—	—
Uterine polyp	Reproductive system and breast disorders	—	—	—	—	—

Other adverse events (7 terms — click to expand)

Reaction	System	Tofacitinib 11mg MR	PF-06651600 100mg	PF-06650833 400mg MR	PF-06650833 400mg MR + Tof…	PF-06650833 400mg MR + PF-…
SARS-CoV-2 test positive	Investigations	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	—	—	—	—	—

Most-reported serious reactions: COVID-19 pneumonia, Coronavirus infection, Femur fracture, Diabetic ketoacidosis, Lumbar spinal stenosis, Skin squamous cell carcinoma recurrent, Uterine leiomyoma, Renal colic.

Data from ClinicalTrials.gov NCT04413617 adverse events section.

Sponsor's own description

Dual objectives of increased efficacy compared to currently available SoC RA drugs and maintaining a favourable benefit - risk relationship.

Publications & conference data

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

JAK/STAT pathway: Extracellular signals, diseases, immunity, and therapeutic regimens.
Hu Q, Bian Q, Rong D, Wang L, et al · · 2023 · cited 190× · PMID 36911202 · DOI 10.3389/fbioe.2023.1110765
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
Metabolic changes in fibroblast-like synoviocytes in rheumatoid arthritis: state of the art review.
Hu Z, Li Y, Zhang L, Jiang Y, et al · · 2024 · cited 23× · PMID 38482018 · DOI 10.3389/fimmu.2024.1250884
Oral IRAK4 inhibitor BAY-1834845 prevents acute respiratory distress syndrome.
Li Q, Li R, Yin H, Wang S, et al · · 2022 · cited 14× · PMID 36076574 · DOI 10.1016/j.biopha.2022.113459
Impact of Janus Kinase Inhibition on the Treatment of Axial Spondyloarthropathies.
Hammitzsch A, Lorenz G, Moog P. · · 2020 · cited 14× · PMID 33193430 · DOI 10.3389/fimmu.2020.591176
Reply.
Danto SI, Peeva E. · · 2026 · PMID 40545973 · DOI 10.1002/art.43291

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
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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 NCT04413617 (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: 7 April 2023

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/NCT04413617.

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