Trial · NCT03120949
Outcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population) | up to Week 126 | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population) | up to Week 126 | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Incidence of Treatment-Emergent Adverse Events of Special Interest (AESI) | up to Week 126 | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Incidence of Treatment-Emergent AEs Leading to Withdrawal of the Study Treatment | up to Week 126 | Safety Population (3 Subjects discontinued treatment due to an AE but they did not have an AE that led to treatment discontinuation.) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Incidence Rate of Treatment Emergent AEs Per Patient-years of Exposure | up to Week 126 | subjects per 100 subject-years | NUMBER | |
| PRIMARY | Incidence Rate of Treatment Emergent SAEs Per Patient-years of Exposure | up to Week 126 | subjects per 100 subject-years | NUMBER | |
| PRIMARY | Incidence Rate of Treatment Emergent AESIs (Safety Population) | up to Week 126 | An AE is defined as treatment-emergent under a given study treatment, if AE's onset date is on or after the date of first dose the corresponding treatment and prior to initiation of the next study treatment, if any. | subjects per 100 subject-years | NUMBER |
| SECONDARY | American College of Rheumatology 20% (ACR20) Response Rates Compare Against Core Baseline Through Week 82 | up to Week 82 | mITT Population Intermediate missing data are imputed using surrounding visits. Response is calculated relative to the core baseline, the last available assessment prior to the first dose of the study treatment in the core study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | American College of Rheumatology 50% (ACR50) Response Rates Compare Against Core Baseline Through Week 82 | up to Week 82 | mITT Population Intermediate missing data are imputed using surrounding visits. Response is calculated relative to the core baseline, the last available assessment prior to the first dose of the study treatment in the core study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | American College of Rheumatology 70% (ACR70) Response Rates Compare Against Core Baseline Through Week 82 | up to Week 82 | mITT Population Intermediate missing data are imputed using surrounding visits. Response is calculated relative to the core baseline, the last available assessment prior to the first dose of the study treatment in the core study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Subjects With Simplified Disease Activity Index (SDAI) Remission Through Week 82 | up to week 82 | Intermediate missing data are imputed using surrounding visits. The Core Baseline value was defined as the baseline value from the core study for subjects that enrol into the OLE study.The OLE Baseline value was defined as the last available measurement prior to the first OLE dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Disease Activity Score 28-joint Count (DAS28) Response Rates Through Week 82 | up to Week 82 | Intermediate missing data are imputed using surrounding visits. The Core Baseline value was defined as the baseline value from the core study for subjects that enrol into the OLE study.The OLE Baseline value was defined as the last available measurement prior to the first OLE dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 12 | Core baseline, Week 12 | mITT Population Subjects with a missing baseline are not included. Intermediate missing data are imputed using surrounding visits. | score on a scale | MEAN |
| SECONDARY | Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 20 | Core baseline, Week 20 | mITT Population Subjects with a missing baseline are not included. Intermediate missing data are imputed using surrounding visits. | score on a scale | MEAN |
| SECONDARY | Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 28 | Core baseline, Week 28 | mITT Population Subjects with a missing baseline are not included. Intermediate missing data are imputed using surrounding visits. | score on a scale | MEAN |
| SECONDARY | Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 40 | Core baseline, Week 40 | mITT Population Subjects with a missing baseline are not included. Intermediate missing data are imputed using surrounding visits. | score on a scale | MEAN |
| SECONDARY | Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 52 | Core baseline, Week 52 | mITT Population Subjects with a missing baseline are not included. Intermediate missing data are imputed using surrounding visits. | score on a scale | MEAN |
| SECONDARY | Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 64 | Core baseline, Week 64 | mITT Population Subjects with a missing baseline are not included. Intermediate missing data are imputed using surrounding visits. | score on a scale | MEAN |
| SECONDARY | Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 82 | Core baseline, Week 82 | mITT Population Subjects with a missing baseline are not included. Intermediate missing data are imputed using surrounding visits. | score on a scale | MEAN |
| SECONDARY | Proportion of Subjects With Health Assessment Questionnaire - Disability Index (HAQ-DI) Improvement Through Week 82 | up to week 82 | Intermediate missing data are imputed using surrounding visits. The OLE Baseline value was defined as the last available measurement prior to the first OLE dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT03120949/outcomes