Trial · NCT02996500
Outcomes34
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 34
Download this page as JSON| 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 |
| SECONDARY | Percentage of Participants With DAS28-4 (CRP) 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 (CRP) 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 | Change From Baseline in DAS28-4 (ESR) at 4, 8 and 12 Weeks | Baseline, 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. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in DAS28-3 (ESR) at 4, 8 and 12 Weeks | Baseline, 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. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in DAS28-4 (CRP) at 4, 8 and 12 Weeks | Baseline, 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. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in DAS28-3 (CRP) at 4, 8 and 12 Weeks | Baseline, 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. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response 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 Achieving American College of Rheumatology 50% (ACR50) Response 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 Achieving American College of Rheumatology 70% (ACR70) Response 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 | Change From Baseline in the Tender/Painful and Swollen Joint Counts at 4, 8 and 12 Weeks | Baseline, 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. | joints | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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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