Trial · NCT02486302
Outcomes52
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 52
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12 | Week 12 | Per-protocol (PP) set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24 | Week 24 | PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12 and Maintained Till 52 Weeks | Week 12 up to Week 52 | PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24 and Maintained Till 52 Weeks | Week 24 up to Week 52 | PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With PsO Who Achieved 75% Improvement From Baseline in Psoriasis Area & Severity Index(PASI75) Score or Physician's Global Assessment(PGA) of Clear or Almost Clear And Dermatology Life Quality Index(DLQI) Total Score of 0 or 1 | Week 12 | PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsO. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Axial Spondyloarthritis (axSpA) Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 12 | Week 12 | PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with axSpA evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Psoriatic Arthritis (PsA) Who Achieved Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 12 | Week 12 | PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsA evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Plaque Psoriasis (PsO) Who Achieved 75% Improvement in Psoriasis Area and Severity Index (PASI75) Score or a Physician's Global Assessment (PGA) of Clear or Almost Clear and DLQI Total Score of 0 or 1 at Week 24 | Week 24 | PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsO evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 24 | Week 24 | PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with axSpA evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Psoriatic Arthritis (PsA) Achieving Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 24 | Week 24 | PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsA evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Treated Set (TS) | Baseline up to Weeks 12, 24, 36, 52 | Treated set included all documented participants who were treated, had at least 1 post-baseline value and had an AE documented. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set | Baseline up to Weeks 12, 24, 36, 52 | PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to Weeks 12, 24, 36 and 52: Treated Set | Baseline up to Weeks 12, 24, 36, 52 | Treated set included all documented participants who were treated, had at least 1 post-baseline value and had an AE documented. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set | Baseline up to Weeks 12, 24, 36, 52 | PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Achieving 28 Joint Disease Activity Score (DAS28) Remission at Weeks 12, 24, 36 and 52 | Weeks 12, 24, 36, 52 | PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA or PsA. Number analyzed signifies participants analyzed for this outcome measure at specified time points. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Patient Global Assessment of Disease Activity (PtGA) Scores at Weeks 12, 24, 36 and 52 | Weeks 12, 24, 36, 52 | PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Number analyzed signifies participants analyzed for this outcome measure at specified time points. | mm | MEAN |
| SECONDARY | Mean Visual Analogue Scale (VAS) Fatigue Scores at Weeks 12, 24, 36 and 52 | Weeks 12, 24, 36, 52 | PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Number analyzed signifies participants analyzed for this outcome measure at specified time points. | mm | MEAN |
| SECONDARY | Mean Visual Analogue Scale (VAS) Pain Scores at Weeks 12, 24, 36 and 52 | Weeks 12, 24, 36, 52 | PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Number analyzed signifies participants analyzed for this outcome at specified time points. | mm | MEAN |
| SECONDARY | Physician Global Assessment (PGA) of Disease Activity Scores at Weeks 12, 24, 36 and 52 | Weeks 12, 24, 36, 52 | PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Number analyzed signifies participants analyzed for this outcome at specified time points. | mm | MEAN |
| SECONDARY | Patient Health Quessionare-2 (PHQ-2) Scores at Weeks 12, 24, 36 and 52 | Weeks 12, 24, 36, 52 | PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Number analyzed signifies participants analyzed for this outcome at specified time points. | units on a scale | 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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