Trial · NCT01557322
Outcomes35
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 35
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With American College of Rheumatology (ACR) Criteria | Baseline | Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure. | participants | NUMBER |
| PRIMARY | Number of Participants With Systemic Features | Baseline | Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable for specified category for each treatment arm, respectively. | participants | NUMBER |
| PRIMARY | Number of Participants With Prior Joint Replacement or Surgery | Baseline | Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure. | participants | NUMBER |
| PRIMARY | Number of Participants With Chest X-Ray Prior to New Therapy | Baseline | Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure. | participants | NUMBER |
| PRIMARY | Number of Participants With Comorbidities | Baseline | Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable for specified category for each treatment arm, respectively. | participants | NUMBER |
| PRIMARY | Body Mass Index (BMI) | Baseline | Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure. | kg/m^2 | MEAN |
| PRIMARY | Blood Pressure (BP) | Baseline | Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable for specified category for each treatment arm, respectively. | millimeter of mercury (mmHg) | MEAN |
| PRIMARY | Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) at Month 60 | Baseline, Month 60 | Analysis population included all enrolled participants with moderate RA at baseline. Here n signifies participants evaluable at each time-point for each treatment arm, respectively. | units on a scale | MEAN |
| PRIMARY | Change From Baseline in Tender Joints Count (TJC) at Month 60 | Baseline, Month 60 | Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable at each time-point for each treatment arm, respectively. | tender joints | MEAN |
| PRIMARY | Change From Baseline in Swollen Joints Count (SJC) at Month 60 | Baseline, Month 60 | Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable at each time-point for each treatment arm, respectively. | swollen joints | MEAN |
| PRIMARY | Change From Baseline in C-Reactive Protein (CRP) Level at Month 60 | Baseline, Month 60 | Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable at each time-point for each treatment arm, respectively. | mg/L | MEAN |
| PRIMARY | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 60 | Baseline, Month 60 | Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable at each time-point for each treatment arm, respectively. | mm/hour | MEAN |
| PRIMARY | Change From Baseline in Patient's Global Assessment (PtGA) of Disease Activity at Month 60 | Baseline, Month 60 | Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable at each time-point for each treatment arm, respectively. | mm | MEAN |
| PRIMARY | Duration of Disease (Rheumatoid Arthritis) | Baseline | Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure. | years | MEAN |
| PRIMARY | Time Since First Rheumatologist Visit | Baseline | Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure. | years | MEAN |
| PRIMARY | Time Since Recalled Symptom Onset | Baseline | Results not reported as this outcome was not evaluated due to lack availability of information on the outcome in BSRBR used for analysis. | ||
| PRIMARY | Number of Participants With Previous and Current Disease Modifying Anti-Rheumatic Drugs (DMARDs) | Baseline | Analysis population included all enrolled participants with moderate RA at baseline. | participants | NUMBER |
| PRIMARY | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Month 60 | Baseline, Month 60 | Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable at each time-point for each treatment arm, respectively. | units on a scale | MEAN |
| PRIMARY | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Month 60 | Baseline, Month 60 | Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable at each time-point for each treatment arm, respectively. | units on a scale | MEAN |
| PRIMARY | Change From Baseline in Euro Quality of Life - 5 Dimensions (EQ-5D) at Month 60 | Baseline, Month 60 | Data not analyzed due to low number of participants available for this measure in BSRBR used for analysis. |
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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