Trial · NCT03158285
Outcomes209
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 209
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24 | Week 24 | Analysis population is full analysis set 1 (FAS1). Participants who achieved ACR 20 response at Week 24 and did not meet any treatment failure (TF) criteria before Week 24 were considered as responders. Participants who met 1 or more TF criteria or with missing data were considered as non-responders. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 | Baseline and Week 24 | Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be missing at random (MAR) and imputed using multiple imputation (MI). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Who Achieved an ACR 50 Response at Week 24 | Week 24 | Analysis population is FAS1. Participants who achieved ACR 50 response at Week 24 and did not meet any TF criteria before Week 24 were considered as responders. Participants who met 1 or more TF criteria or with missing data were considered as non-responders. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved Psoriasis Response With IGA Score of 0 (Cleared) or 1 (Minimal) and >=2 Grade Reduction From Baseline at Week 24 Among Participants With >=3% BSA Psoriatic Involvement and IGA Score of >=2 (Mild) at Baseline | Week 24 | FAS1 among participants with \>=3% BSA psoriatic involvement and an IGA score \>=2 (mild) at baseline. Participants who achieved psoriasis IGA response at Week 24 and did not meet any TF criteria before Week 24 were considered as responders. Participants who met 1 or more TF criteria or with missing data were considered as non-responders. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16 | Week 16 | Analysis population is FAS1. Participants who achieved ACR 20 response at Week 16 and did not meet any TF criteria before Week 16 were considered as responders. Participants who met 1 or more TF criteria before Week 16 or with missing data were considered as non-responders. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Modified Van Der Heijde-Sharp (vdH-S) Score at Week 24 | Baseline and Week 24 | FAS1 for structural damage (FAS1-SD) included all participants who received at least 1 dose (complete/partial) of study agent according to randomized treatment group regardless of treatment actually received. Observed data were used regardless if 1 or more TF criteria were met. Missing data were assumed to be MAR and imputed using MI. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Resolution of Enthesitis at Week 24 Among the Participants With Enthesitis at Baseline | Week 24 | FAS1 among participants with enthesitis at baseline pooled from CNTO1959PSA3001 (NCT03162796) and CNTO1959PSA3002 (NCT03158285) studies. Participants with enthesitis resolution at Week 24 and did not meet any TF criteria before Week 24 considered responders. Participants who met 1/more TF criteria or with missing data considered non-responders. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Resolution of Dactylitis at Week 24 Among the Participants With Dactylitis at Baseline | Week 24 | FAS1 among participants with dactylitis at baseline pooled from CNTO1959PSA3001 (NCT03162796) and CNTO1959PSA3002 (NCT03158285) studies. Participants with dactylitis resolution at Week 24 and did not meet any TF criteria before Week 24 considered responders. Participants who met 1/more TF criteria or with missing data considered non-responders. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Enthesitis Score (Based on LEI) at Week 24 Among the Participants With Enthesitis at Baseline | Baseline and Week 24 | Analysis population is FAS1 among participants with enthesitis at baseline pooled from both CNTO1959PSA3001 (NCT03162796) and CNTO1959PSA3002 (NCT03158285) studies. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random and imputed using multiple imputation. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Dactylitis Scores at Week 24 Among the Participants With Dactylitis at Baseline | Baseline and Week 24 | Analysis population is FAS1 among participants with dactylitis at baseline pooled from both from CNTO1959PSA3001 (NCT03162796) and CNTO1959PSA3002 (NCT03158285) studies. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random and imputed using multiple imputation. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24 | Baseline and Week 24 | Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be missing at random (MAR) and imputed using multiple imputation (MI). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Disease Activity Score (DAS28) (C-reactive Protein [CRP]) Score at Week 24 | Baseline and Week 24 | Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be missing at random (MAR) and imputed using multiple imputation (MI). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) at Week 24 | Baseline and Week 24 | Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be missing at random (MAR) and imputed using multiple imputation (MI). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 16 | Week 16 | Analysis population is FAS1. Participants who achieved ACR 50 response at Week 16 and did not meet any TF criteria before Week 16 were considered as responders. Participants who met 1 or more TF criteria or with missing data were considered as non-responders. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 70 Response at Week 24 | Week 24 | Analysis population is FAS1. Participants who achieved ACR 70 response at Week 24 and did not meet any TF criteria before Week 24 were considered as responders. Participants who met 1 or more TF criteria or with missing data were considered as non-responders. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved ACR 20 Response Through Week 24 | Weeks 2, 4, 8, 12, 16, 20 and 24 | Analysis population is FAS1. Participants who achieved ACR 20 response at a specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved ACR 50 Response Through Week 24 | Weeks 2, 4, 8, 12, 16, 20 and 24 | Analysis population is FAS1. Participants who achieved ACR 50 response at a specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved ACR 70 Response Through Week 24 | Weeks 2, 4, 8, 12, 16, 20 and 24 | Analysis population is FAS1. Participants who achieved ACR 70 response at a specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders. | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24 | Analysis population is FAS1. Here 'n' (number analyzed) signifies number of participants with observed data regardless meeting TF criteria at specified categories. | percent change | MEAN |
| SECONDARY | Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24 | Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24 | Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be missing at random (MAR) and imputed using multiple imputation (MI). | units on a scale | LEAST_SQUARES_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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