Trial · NCT02996500
Safety and Efficacy of Pf-06650833 In Subjects With Rheumatoid Arthritis, With An Inadequate Response To Methotrexate
NCT02996500, Phase 2, Completed, Pfizer; results first posted 2020-02-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Pf-06650833 In Subjects With Rheumatoid Arthritis, With An Inadequate Response To Methotrexate. Trials, record NCT02996500. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02996500
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Pf-06650833 In Subjects With Rheumatoid Arthritis, With An Inadequate Response To Methotrexate
- NCT number
- NCT02996500
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 269 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Rheumatoid Arthritis
- Interventions
- PF-06650833, Placebo, Tofacitinib
- First posted
- 2016-12-19
- Last updated
- 2020-02-27
- Other registries' IDs
- eudract:2016-002337-30
- Results first posted
- 2020-02-27
Source ClinicalTrials.gov
Registered outcomes34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Simplified Disease Activity Index (SDAI) at Week 12 | 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 disease activity, and \>26 = high disease activity. The primary analysis utilized a Bayesian ANCOVA model with an informative placebo prior distribution with borrowing from tofacitinib historical placebo data. The confidence interval was credible interval in this statistical analysis. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints. |
| Secondary | Change From Baseline in SDAI at Weeks 4 and 8 | 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 observed data. 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. |
| Secondary | Percentage of Participants With SDAI Low Disease Activity Score (LDAS) (SDAI <=11) at 4, 8, and 12 Weeks | 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. |
| Secondary | Percentage of Participants With SDAI Remission (SDAI <=3.3) at 4, 8, and 12 Weeks | 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. |
| Secondary | 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 | 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 study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints. |
| Secondary | Percentage of Participants With DAS28-3 (ESR) LDAS (DAS28 <3.2) at 4, 8, and 12 Weeks | 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 control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints. |
| Secondary | 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 | 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 study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints. |
| Secondary | Percentage of Participants With DAS28-3 (CRP) LDAS (DAS28 <3.2) at 4, 8, and 12 Weeks | 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. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints. |
| Secondary | Percentage of Participants With DAS28-4 (ESR) Remission (DAS28 <2.6) at 4, 8 and 12 Weeks | 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 study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints. |
| Secondary | Percentage of Participants With DAS28-3 (ESR) Remission (DAS28 <2.6) at 4, 8 and 12 Weeks | 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 control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints. |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 registered outcomesOutcomes34
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Simplified Disease Activity Index (SDAI) at Week 12 | Baseline and Week 12 | The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in SDAI at Weeks 4 and 8 | Baseline, Weeks 4 and 8 | The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm. | units on a scale | MEAN |
| SECONDARY | Percentage of Participants With SDAI Low Disease Activity Score (LDAS) (SDAI <=11) at 4, 8, and 12 Weeks | Weeks 4, 8 and 12 | The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With SDAI Remission (SDAI <=3.3) at 4, 8, and 12 Weeks | Weeks 4, 8 and 12 | The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm. | percentage of participants | NUMBER |
| SECONDARY | 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 | Weeks 4, 8 and 12 | The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With DAS28-3 (ESR) LDAS (DAS28 <3.2) at 4, 8, and 12 Weeks | Weeks 4, 8 and 12 | The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm. | percentage of participants | NUMBER |
| SECONDARY | 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 | Weeks 4, 8 and 12 | The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With DAS28-3 (CRP) LDAS (DAS28 <3.2) at 4, 8, and 12 Weeks | Weeks 4, 8 and 12 | The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With DAS28-4 (ESR) Remission (DAS28 <2.6) at 4, 8 and 12 Weeks | Weeks 4, 8 and 12 | The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With DAS28-3 (ESR) Remission (DAS28 <2.6) at 4, 8 and 12 Weeks | Weeks 4, 8 and 12 | The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm. | percentage of participants | NUMBER |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 outcomesResults by group746
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Simplified Disease Activity Index (SDAI) at Week 12 | Placebo | -13.87 | 95% Confidence Interval -17.70 to -10.02 | units on a scale | |
| Change From Baseline in the Simplified Disease Activity Index (SDAI) at Week 12 | PF-06650833 20 mg | -21.71 | 95% Confidence Interval -26.14 to -17.20 | units on a scale | |
| Change From Baseline in the Simplified Disease Activity Index (SDAI) at Week 12 | PF-06650833 60 mg | -22.83 | 95% Confidence Interval -26.57 to -19.20 | units on a scale | |
| Change From Baseline in the Simplified Disease Activity Index (SDAI) at Week 12 | PF-06650833 200 mg | -24.77 | 95% Confidence Interval -28.54 to -21.08 | units on a scale | |
| Change From Baseline in the Simplified Disease Activity Index (SDAI) at Week 12 | PF-06650833 400 mg | -25.16 | 95% Confidence Interval -28.85 to -21.39 | units on a scale | |
| Change From Baseline in SDAI at Weeks 4 and 8 | Placebo | Week 4 | -10.78 | 95% Confidence Interval -15.07 to -6.49 | units on a scale |
| Change From Baseline in SDAI at Weeks 4 and 8 | PF-06650833 20 mg | Week 4 | -12.39 | 95% Confidence Interval -14.68 to -10.10 | units on a scale |
| Change From Baseline in SDAI at Weeks 4 and 8 | PF-06650833 60 mg | Week 4 | -14.29 | 95% Confidence Interval -16.87 to -11.71 | units on a scale |
| Change From Baseline in SDAI at Weeks 4 and 8 | PF-06650833 200 mg | Week 4 | -13.56 | 95% Confidence Interval -17.25 to -9.86 | units on a scale |
| Change From Baseline in SDAI at Weeks 4 and 8 | PF-06650833 400 mg | Week 4 | -12.30 | 95% Confidence Interval -15.46 to -9.14 | units on a scale |
1 to 10 of 746Source ClinicalTrials.gov
See all 746 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 39 | |
| Overall Study | STARTED | Tofa 10 mg | 43 | |
| Overall Study | STARTED | PF-06650833 20 mg | 39 | |
| Overall Study | STARTED | PF-06650833 60 mg | 50 | |
| Overall Study | STARTED | PF-06650833 200 mg | 50 | |
| Overall Study | STARTED | PF-06650833 400 mg | 48 | |
| Overall Study | COMPLETED | Placebo | 31 | |
| Overall Study | COMPLETED | Tofa 10 mg | 42 | |
| Overall Study | COMPLETED | PF-06650833 20 mg | 29 | |
| Overall Study | COMPLETED | PF-06650833 60 mg | 46 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events108
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 | Abdominal pain upper | Gastrointestinal disorders | Placebo | 0 | 39 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Tofa 10 mg | 1 | 43 | |
| other | Abdominal pain upper | Gastrointestinal disorders | PF-06650833 20 mg | 2 | 39 | |
| other | Abdominal pain upper | Gastrointestinal disorders | PF-06650833 60 mg | 0 | 50 | |
| other | Abdominal pain upper | Gastrointestinal disorders | PF-06650833 200 mg | 1 | 50 | |
| other | Abdominal pain upper | Gastrointestinal disorders | PF-06650833 400 mg | 0 | 48 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 1 | 39 | |
| other | Upper respiratory tract infection | Infections and infestations | Tofa 10 mg | 2 | 43 | |
| other | Upper respiratory tract infection | Infections and infestations | PF-06650833 20 mg | 2 | 39 | |
| other | Upper respiratory tract infection | Infections and infestations | PF-06650833 60 mg | 0 | 50 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 39 |
| Total, all-cause mortality | Tofa 10 mg | 0 | 43 |
| Total, all-cause mortality | PF-06650833 20 mg | 0 | 39 |
| Total, all-cause mortality | PF-06650833 60 mg | 0 | 50 |
| Total, all-cause mortality | PF-06650833 200 mg | 0 | 50 |
| Total, all-cause mortality | PF-06650833 400 mg | 0 | 48 |
| Total, other adverse events | Placebo | 10 | 39 |
| Total, other adverse events | Tofa 10 mg | 8 | 43 |
| Total, other adverse events | PF-06650833 20 mg | 12 | 39 |
| Total, other adverse events | PF-06650833 60 mg | 11 | 50 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 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.
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GET https://conductscience.org/api/trials/v1/NCT02996500/registered?page=2