Trial · NCT01715896
Outcomes30
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 30
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169 | Day 169 | The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169 | Day 169 | The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169 | Day 169 | The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 169 | Day 169 | The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Achieved Health Assessment Questionnaire Disability Index (HAQ-DI) Score Improvement From Baseline and >= 0.25 at Day 169 | Day 169 | The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Baseline up to Day 169 | The safety population included all participants who received any amount of study medication. | participants | NUMBER |
| SECONDARY | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Baseline up to Day 169 | The safety population included all participants who received any amount of investigational product. | participants | NUMBER |
| SECONDARY | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Baseline up to Day 169 | The safety population included all participants who received any amount of study medication. | participants | NUMBER |
| SECONDARY | Number of Participants With Pulmonary Function Test Values Below Threshold Values Based on Percent Change From Baseline at Day 85 and 169 | Day 85 and 169 | The safety population included all participants who received any amount of investigational product. Here n signifies participants who were evaluable for this measure for the specified threshold value mentioned parameter for each arm, respectively. | participants | NUMBER |
| SECONDARY | Dyspnea Score at Day 169 | Day 169 | The safety population included all participants who received any amount of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 169 | Baseline and Day 169 | The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Continuous American College of Rheumatology (ACRn) Score at Day 169 | Baseline up to Day 169 | The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively. | units on a scale | MEAN |
| SECONDARY | American College of Rheumatology (ACR) Hybrid Score at Day 169 | Day 169 | The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. | units on a scale | MEDIAN |
| SECONDARY | Number of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169 | Day 169 | The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. | participants | NUMBER |
| SECONDARY | Number of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169 | Day 169 | The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. | participants | NUMBER |
| SECONDARY | Time to Onset DAS28 (CRP) Remission at Day 169 | Day 169 | The mITT population analysis set included all participants who were at risk in the treatment group corresponding to their randomized treatment group. Here, N is number of participants analysed for this outcome measure. | days | MEDIAN |
| SECONDARY | Duration of DAS28 (CRP) Remission at Day 169 | Day 169 | The mITT population analysis set included all participants who were at risk in the treatment group corresponding to their randomized treatment group. Here, N is number of participants analysed for this outcome measure. | days | MEAN |
| SECONDARY | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) < 2.6 at Day 169 | Day 169 | The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved Simplified Disease Activity Index (SDAI) Remission at Day 169 | Day 169 | The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Day 169 | Day 169 | The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. | 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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01715896/outcomes