Trial · NCT00975130
Registered outcomes174
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 174
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Month 6 | Month 6 | EULAR response was assessed at the end of Month 6 by the Disease Activity Score using the 28 tender and swollen joint count calculated with erythrocyte sedimentation rate values (DAS28-ESR). A good response was defined as a decrease \>1.2 units and a final DAS28-ESR \< 3.2 units, while a moderate response was defined as a decrease \> 1.2 units and final DAS28-ESR \>= 3.2 units, OR a decrease of 0.6 to 1.2 units AND final DAS28-ESR \<= 5.1 units |
| Primary | Number of Participants Experiencing Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at the Start of Month 11 and End of Month 12 | Start of Month 11, End of Month 12 | The number of participants experiencing DAS28-ESR remission was evaluated at the start of study Month 11 and the end of study Month 12. The DAS28-ESR is expressed on a unit on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR \<2.6. |
| Secondary | Mean Change From Baseline in the Number of Swollen Joints by Concomitant Methotrexate (MTX) Dose at Month 2, Month 4, and Month 6 | Baseline, Month 2, Month 4, Month 6 | The mean change from baseline in the mean number of swollen joints was calculated at study Month 2, Month 4, and Month 6 by concomitant MTX dose (low \< 10mg/wk, medium \>= 10 to \< 15 mg/week, and high \>=15 mg/week). A total of 28 joints were evaluated. |
| Secondary | Mean Change From Baseline in the Number of Swollen Joints by Disease Modifying Antirheumatic Drug (DMARD) Background Treatment at Month 2, Month 4, and Month 6 | Baseline, Month 2, Month 4, Month 6 | The mean change from baseline in the number of swollen joints was calculated by participant baseline background DMARD treatment regimen at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only. |
| Secondary | Mean Change From Baseline in the Number of Swollen Joints by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 | Baseline, Month 2, Month 4, Month 6 | The mean change from baseline in the number of swollen joints by participant baseline concomitant corticosteroid treatment was calculated at study Month 2, Month 4, and Month 6 . A total of 28 joints were evaluated. |
| Secondary | Mean Change From Baseline in the Number of Swollen Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6 | Baseline, Month 2, Month 4, Month 6 | The mean change from baseline in the mean number of swollen joints by the number of baseline participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. |
| Secondary | Mean Change From Baseline in the Number of Swollen Joints by Duration of Disease at Month 2, Month 4, and Month 6 | Baseline, Month 2, Month 4, Month 6 | The mean change from baseline in the mean number of swollen joints was calculated by the participant duration of disease at study Month 2, Month 4, and Month 6. The participant duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. A total of 28 joints were evaluated. |
| Secondary | Mean Change From Baseline in the Number of Swollen Joints by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6 | Baseline, Month 2, Month 4, Month 6 | The mean change from baseline in the number of swollen joints by participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6 by the participant's level of baseline disease activity, as measured by DAS28-ESR. A total of 28 joints were evaluated. DAS28-ESR \> 5.1 = high disease activity, DAS28-ESR \< 3.2 to \< =5.1 = low disease activity, and DAS28-ESR \<2.6 = remission. |
| Secondary | Mean Change From Baseline in the Number of Swollen Joints by Baseline Rheumatoid Factor (RF) Level at Month 2, Month 4, and Month 6 | Baseline, Month 2, Month 4, Month 6 | The change from baseline in the mean number of swollen joints was calculated by the participant baseline level of RF at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. |
| Secondary | Mean Change From Baseline in the Number of Swollen Joints by Baseline Anti-Cyclic Citrullinated Antibody (Anti-CCP) Level at Month 2, Month 4, and Month 6 | Baseline, Month 2, Month 4, Month 6 | The change from baseline in the mean number of swollen joints was calculated by the participant baseline level of anti-CCP at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. |
| Secondary | Mean Change From Baseline in the Number of Swollen Joints by Smoking History at Month 2, Month 4, and Month 6 | Baseline, Month 2, Month 4, Month 6 | The change from baseline in the mean number of swollen joints was calculated by the baseline participant smoking status at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked. |
| Secondary | Mean Change From Baseline in the Number of Swollen Joints by Eligibility for Anti-Tumor Necrosis Factor (Anti-TNF) Treatment at Month 2, Month 4, and Month 6 | Baseline, Month 2, Month 4, Month 6 | The change from baseline in the mean number of swollen joints was calculated by the baseline participant eligibility for anti-TNF treatment at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. |
| Secondary | Mean Change From Baseline in the Number of Swollen Joints by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | Baseline, Month 2, Month 4, Month 6 | The mean change from baseline in the number of swollen joints was calculated by the participant baseline expectation of treatment outcome at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst). |
| Secondary | Mean Change From Baseline in the Number of Swollen Joints by Physician Experience Level at Month 2, Month 4, and Month 6 | Baseline, Month 2, Month 4, Month 6 | The mean change from baseline in the number of swollen joints was calculated by the physician experience level at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis. |
| Secondary | Mean Change From Baseline in the Number of Swollen Joints by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6 | Baseline, Month 2, Month 4, Month 6 | The mean change from baseline in the number of swollen joints was calculated by the physician experience level with biologics at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics. |
| Secondary | Mean Change From Baseline in the Number of Swollen Joints by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6 | Baseline, Month 2, Month 4, Month 6 | The mean change from baseline in the number of swollen joints was calculated by the baseline number of patients the physician treats with biologics at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. The number of patients treated with biologics is defined as the number of patients treated by the physician in the last month with biologics for rheumatoid arthritis. |
| Secondary | Mean Change From Baseline in the Number of Swollen Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | Baseline, Month 2, Month 4, Month 6 | The mean change from baseline in the number of swollen joints was calculated by the physician's expectation of treatment outcome at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. The physician's expectation of treatment outcomes was assessed at the start of Month 4 at which time physicians were asked to rate their expectations of treatment outcome in each participant as: high disease activity, moderate disease activity, low disease activity, or remission. |
| Secondary | Mean Change From Baseline in the Number of Tender Joints by Concomitant MTX Dose at Month 2, Month 4, and Month 6 | Baseline, Month 2, Month 4, Month 6 | The mean change from baseline in the number of tender joints was calculated by participant concomitant MTX dose (low \< 10mg/wk, medium \>= 10 to \< 15 mg/week, and high \>=15 mg/week) at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. |
| Secondary | Mean Change From Baseline in the Number of Tender Joints by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6 | Baseline, Month 2, Month 4, Month 6 | The mean change from baseline in the number of tender joints was calculated by participant background DMARD treatment at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only. |
| Secondary | Mean Change From Baseline in the Number of Tender Joints by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 | Baseline, Month 2, Month 4, Month 6 | The mean change from baseline in the number of tender joints was calculated by participant baseline concomitant steroid treatment at study Month 2, Month 4, and Month 6. A total 28 joints were evaluated. |
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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