Trial · NCT03104400
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 | Baseline and Week 12 | Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 | Baseline and Week 12 | Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with longitudinal data from observed cases up to Week 12 was used. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving a Static Investigator Global Assessment (sIGA) of Psoriasis of 0 or 1 and at Least a 2-point Improvement From Baseline (sIGA 0/1) at Week 16 | Baseline and Week 16 | Full analysis set participants with a Baseline sIGA score ≥ 2; participants who prematurely discontinued from study drug prior to Week 16 or for whom sIGA data were missing at Week 16 were considered non-responders. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response at Week 16 | Baseline and Week 16 | Full analysis set participants with Baseline psoriasis BSA involvement ≥ 3%; participants who prematurely discontinued from study drug prior to Week 16 or for whom PASI data were missing at Week 16 were considered non-responders. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Modified PsA Total Sharp/Van Der Heijde Score (mTSS) at Week 24 | Baseline and Week 24 | Full analysis set participants with available data at Baseline; linear extrapolation was used for participants who discontinued prior to Week 24 or who were rescued prior to Week 24. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24 | Week 24 | Full analysis set; participants who prematurely discontinued from study drug prior to Week 24 or for whom data were missing at Week 24, or who met the rescue criteria at Week 16 were considered non-responders. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Resolution of Enthesitis at Week 24 | Week 24 | Full analysis set participants with a Baseline LEI \> 0; participants who prematurely discontinued from study drug prior to Week 24 or for whom data were missing at Week 24, or who met the rescue criteria at Week 16 were considered non-responders. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With an ACR20 Response at Week 12 - Non-inferiority Versus Adalimumab | Baseline and Week 12 | Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12 | Baseline and Week 12 | Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with longitudinal data from observed cases up to Week 12 was used. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12 | Baseline and Week 12 | Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with longitudinal data from observed cases up to Week 12 was used. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With an ACR20 Response at Week 12 - Superiority Versus Adalimumab | Baseline and Week 12 | Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Resolution of Dactylitis at Week 24 | Week 24 | Full analysis set participants with a Baseline LDI \> 0; participants who prematurely discontinued from study drug prior to Week 24 or for whom data were missing at Week 24, or who met the rescue criteria at Week 16 were considered non-responders. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Patient's Assessment of Pain - Superiority Versus Adalimumab | Baseline and Week 12 | Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with longitudinal data from observed cases up to Week 12 was used. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in HAQ-DI - Superiority Versus Adalimumab | Baseline and Week 12 | Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with longitudinal data from observed cases up to Week 12 was used. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Self-Assessment of Psoriasis Symptoms (SAPS) Questionnaire at Week 16 | Baseline and Week 16 | Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with longitudinal data from observed cases up to Week 16 was used. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12 | Baseline and Week 12 | Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12 | Baseline and Week 12 | Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2 | Baseline and Week 2 | Full analysis set; participants who prematurely discontinued from study drug prior to Week 2 or for whom ACR data were missing at Week 2 were considered non-responders. | percentage of participants | NUMBER |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT03104400/outcomes