Trial · NCT01706926
Outcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85 | Baseline and Day 85 | The modified intent-to-treat (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 |
| 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 |
| SECONDARY | Percentage 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 dose of investigational product. | percentage of 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 dose 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 dose of investigational product. | participants | NUMBER |
| SECONDARY | Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169 | Day 169 | The safety population included all participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified threshold value mentioned parameter for each arm, respectively. | percent of pulmonary test values | NUMBER |
| SECONDARY | Dyspnea Score at Day 169 | Day 169 | The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure. | units on a scale | MEAN |
| SECONDARY | Oxygen Saturation Level at Day 169 | Day 169 | The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure. | percent saturation | MEAN |
| SECONDARY | 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 |
| SECONDARY | 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 |
| 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 (number of participants analyzed) signifies participants who were evaluable for this measure. | units on a scale | MEAN |
| SECONDARY | Percentage 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. | percentage of participants | NUMBER |
| SECONDARY | Percentage 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. | percentage of participants | NUMBER |
| SECONDARY | Mean Change From Baseline in Swollen and Tender Joint Count 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. | joint count | MEAN |
| SECONDARY | Mean Change From Baseline in Patient Assessment of Pain 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. | mm | MEAN |
| SECONDARY | Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity 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. | mm | MEAN |
| SECONDARY | Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) 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. | cm | MEAN |
| SECONDARY | Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) 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 | Ratio of Change From Baseline in C-Reactive Protein (CRP) at Day 169 | Baseline, Day 169 | The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here N (Number of participants analyzed) signifies those participants who were evaluable for this measure. | ratio | GEOMETRIC_MEAN |
| SECONDARY | Ratio of Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Day 169 | Baseline, Day 169 | The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here N (Number of participants analyzed) signifies those participants who were evaluable for this measure. | ratio | GEOMETRIC_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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT01706926/outcomes