Trial · NCT04413617
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
NCT04413617, Phase 2, Completed, Pfizer; results first posted 2023-04-07
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. 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. Trials, record NCT04413617. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04413617
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT04413617
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 460 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Rheumatoid Arthritis
- Interventions
- PF-06650833, PF-06651600, Tofacitinib
- First posted
- 2020-06-04
- Last updated
- 2023-04-07
- Other registries' IDs
- eudract:2019-002676-14
- Results first posted
- 2023-04-07
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline (BL) in Disease Activity Score (DAS)28-C Reactive Protein (CRP) at Week 12 | 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 negative value in change from BL indicates an improvement. Mixed Model Repeated Measures was used for statistical analysis, which used the change from BL of DAS28-CRP as an outcome and treatment, scheduled study visit, BL value of DAS28-CRP, treatment by visit interaction and BL by visit interaction as fixed effects. The model used the unstructured covariance matrix. |
| Secondary | DAS28-CRP Remission (<2.6) Rates at Week 24 | 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) |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs), and Withdrawals Due to TEAEs | 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 first dose of study drug and up to follow-up visit that were absent before treatment or that worsened after treatment. AEs presented below were TEAEs. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE. |
| Secondary | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | From BL to Week 28 | Clinical laboratory abnormality was determined at the investigator's discretion. |
| Secondary | Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria | 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 |
| Secondary | Number of Participants With Adverse Events of Special Interest | 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 with AEs mentioned above were reported in the table below. |
| Secondary | Change From Baseline in DAS28-CRP at Week 24 | 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 improvement. |
| Secondary | American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24 | 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 missingness due to COVID-19 and missing components at a given visit) |
| Secondary | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | 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 calculated by Pfizer from TJC68. Higher scores indicate higher level of disability. |
| Secondary | Change From Baseline in the Physician's Global Assessment (PhGA) of Arthritis at Week 12 and Week 24 | 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline (BL) in Disease Activity Score (DAS)28-C Reactive Protein (CRP) at Week 12 | BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12 | The primary efficacy endpoint used Modified Intent to Treat (mITT) data set, which included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the randomized intervention. Participants with non-missing data at a given visit were included. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | DAS28-CRP Remission (<2.6) Rates at Week 24 | Week 24 | The NRI data set included responders, non-responders, and non-responder assigned by NRI after removal of missingness due to COVID-19 and missing components at a given visit. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs), and Withdrawals Due to TEAEs | From first dose of study intervention (Day 1) to Week 28 | The safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | From BL to Week 28 | The analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable laboratory values were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria | From BL to Week 28 | The safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable vital signs data were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Events of Special Interest | From first dose of study intervention (Day 1) to Week 28 | The safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in DAS28-CRP at Week 24 | BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 24 | This endpoint used mITT data set, which included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the randomized intervention. Participants with non-missing data at a given visit were included. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24 | BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12, Week 24 | This endpoint used NRI data set included responders, non-responders, and non-responder assigned by NRI after removal of missingness due to COVID-19 and missing components at a given visit. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12, Week 24 | This endpoint used mITT data set, which included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the randomized intervention. Participants with non-missing data at a given visit were included. | Joints | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Physician's Global Assessment (PhGA) of Arthritis at Week 12 and Week 24 | BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12, Week 24 | This endpoint used mITT data set, which included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the randomized intervention. Participants with non-missing data at a given visit were included. | Units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group440
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline (BL) in Disease Activity Score (DAS)28-C Reactive Protein (CRP) at Week 12 | PF-06650833 400mg MR + Tofacitinib 11mg MR | -2.65 | 90% Confidence Interval -2.84 to -2.46 | Units on a scale | |
| Change From Baseline (BL) in Disease Activity Score (DAS)28-C Reactive Protein (CRP) at Week 12 | PF-06650833 400mg MR + PF-06651600 100mg | -2.35 | 90% Confidence Interval -2.54 to -2.15 | Units on a scale | |
| Change From Baseline (BL) in Disease Activity Score (DAS)28-C Reactive Protein (CRP) at Week 12 | Tofacitinib 11mg MR | -2.30 | 90% Confidence Interval -2.49 to -2.11 | Units on a scale | |
| Change From Baseline (BL) in Disease Activity Score (DAS)28-C Reactive Protein (CRP) at Week 12 | PF-06651600 100mg | -2.20 | 90% Confidence Interval -2.43 to -1.98 | Units on a scale | |
| Change From Baseline (BL) in Disease Activity Score (DAS)28-C Reactive Protein (CRP) at Week 12 | PF-06650833 400mg MR | -1.82 | 90% Confidence Interval -2.04 to -1.60 | Units on a scale | |
| DAS28-CRP Remission (<2.6) Rates at Week 24 | PF-06650833 400mg MR + Tofacitinib 11mg MR | 40.8 | 90% Confidence Interval 32.6 to 48.7 | Percentage of participants | |
| DAS28-CRP Remission (<2.6) Rates at Week 24 | PF-06650833 400mg MR + PF-06651600 100mg | 31.3 | 90% Confidence Interval 24.1 to 39.8 | Percentage of participants | |
| DAS28-CRP Remission (<2.6) Rates at Week 24 | Tofacitinib 11mg MR | 24.0 | 90% Confidence Interval 17.1 to 31.8 | Percentage of participants | |
| DAS28-CRP Remission (<2.6) Rates at Week 24 | PF-06651600 100mg | 22.4 | 90% Confidence Interval 14.8 to 31.3 | Percentage of participants | |
| DAS28-CRP Remission (<2.6) Rates at Week 24 | PF-06650833 400mg MR | 11.8 | 90% Confidence Interval 6.7 to 19.3 | Percentage of participants |
1 to 10 of 440Source ClinicalTrials.gov
See all 440 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tofacitinib 11mg MR | 102 | |
| Overall Study | STARTED | PF-06651600 100mg | 77 | |
| Overall Study | STARTED | PF-06650833 400mg MR | 77 | |
| Overall Study | STARTED | PF-06650833 400mg MR + Tofacitinib 11mg MR | 103 | |
| Overall Study | STARTED | PF-06650833 400mg MR + PF-06651600 100mg | 101 | |
| Overall Study | COMPLETED | Tofacitinib 11mg MR | 95 | |
| Overall Study | COMPLETED | PF-06651600 100mg | 71 | |
| Overall Study | COMPLETED | PF-06650833 400mg MR | 73 | |
| Overall Study | COMPLETED | PF-06650833 400mg MR + Tofacitinib 11mg MR | 95 | |
| Overall Study | COMPLETED | PF-06650833 400mg MR + PF-06651600 100mg | 96 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events85
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Tofacitinib 11mg MR | 4 | 102 | |
| other | Nausea | Gastrointestinal disorders | PF-06651600 100mg | 5 | 77 | |
| other | Nausea | Gastrointestinal disorders | PF-06650833 400mg MR | 2 | 77 | |
| other | Nausea | Gastrointestinal disorders | PF-06650833 400mg MR + Tofacitinib 11mg MR | 1 | 103 | |
| other | Nausea | Gastrointestinal disorders | PF-06650833 400mg MR + PF-06651600 100mg | 3 | 101 | |
| other | Nasopharyngitis | Infections and infestations | Tofacitinib 11mg MR | 3 | 102 | |
| other | Nasopharyngitis | Infections and infestations | PF-06651600 100mg | 2 | 77 | |
| other | Nasopharyngitis | Infections and infestations | PF-06650833 400mg MR | 1 | 77 | |
| other | Nasopharyngitis | Infections and infestations | PF-06650833 400mg MR + Tofacitinib 11mg MR | 3 | 103 | |
| other | Nasopharyngitis | Infections and infestations | PF-06650833 400mg MR + PF-06651600 100mg | 6 | 101 |
1 to 10 of 85Source ClinicalTrials.gov
See all 85 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tofacitinib 11mg MR | 1 | 102 |
| Total, all-cause mortality | PF-06651600 100mg | 0 | 77 |
| Total, all-cause mortality | PF-06650833 400mg MR | 0 | 77 |
| Total, all-cause mortality | PF-06650833 400mg MR + Tofacitinib 11mg MR | 0 | 103 |
| Total, all-cause mortality | PF-06650833 400mg MR + PF-06651600 100mg | 0 | 101 |
| Total, other adverse events | Tofacitinib 11mg MR | 24 | 102 |
| Total, other adverse events | PF-06651600 100mg | 18 | 77 |
| Total, other adverse events | PF-06650833 400mg MR | 11 | 77 |
| Total, other adverse events | PF-06650833 400mg MR + Tofacitinib 11mg MR | 19 | 103 |
| Total, other adverse events | PF-06650833 400mg MR + PF-06651600 100mg | 26 | 101 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04413617
GET https://conductscience.org/api/trials/v1/NCT04413617/results?page=2