Trial · NCT00424294
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 | Week 12 | FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Missing values were imputed using last observation carried forward (LOCF) method. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 1, 2, 4 and 8 | Week 1, 2, 4, 8 | FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Missing values were imputed using LOCF method. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 1, 2, 4, 8, 12 | FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Missing values were imputed using LOCF method. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 1, 2, 4, 8, 12 | FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Missing values were imputed using LOCF method. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Tender/Painful Joint Count (TJC) at Week 1, 2, 4, 8 and 12 | Baseline, Week 1, 2, 4, 8, 12 | FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,n signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used. | tender/painful joints | MEAN |
| SECONDARY | Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12 | Baseline, Week 1, 2, 4, 8, 12 | FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,n signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used. | swollen joints | MEAN |
| SECONDARY | Change From Baseline in Patient's Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12 | Baseline, Week 1, 2, 4, 8, 12 | FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,n signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used. | mm | MEAN |
| SECONDARY | Change From Baseline in Patient's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12 | Baseline, Week 1, 2, 4, 8, 12 | FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,n signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Physician's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12 | Baseline, Week 1, 2, 4, 8, 12 | FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,n signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 1, 2, 4, 8 and 12 | Baseline, Week 1, 2, 4, 8, 12 | FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,n signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 8 and 12 | Baseline, Week 1, 2, 4, 8, 12 | FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,n signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used. | milligram per deciliter (mg/dL) | MEAN |
| SECONDARY | Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 8 and 12 | Baseline, Week 1, 2, 4, 8, 12 | FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,n signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Duration of Morning Stiffness at Week 1, 2, 4, 8 and 12 | Baseline, Week 1, 2, 4, 8, 12 | FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,n signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used. | hour | MEAN |
| SECONDARY | Number of Participants Who Withdrew From Study Due to Lack of Efficacy | Baseline up to Week 12 | FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. | participants | NUMBER |
| SECONDARY | Time to Withdrawal Due to Lack of Efficacy | Baseline up to Week 12 | Median time and corresponding confidence interval (CI) were not estimable because only less than half of the participants withdrew from study due to lack of efficacy and hence, were insufficient for the analysis. | ||
| OTHER_PRE_SPECIFIED | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 28 days after last dose | Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Adverse Events by Severity | Baseline up to 28 days after last dose | Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. | adverse events | NUMBER |
| SECONDARY | Number of Participants With Clinical Laboratory Abnormalities | Baseline up to Week 13 | Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Change From Baseline in Systolic and Diastolic Blood Pressure at Day 7, 14, 21, 28, 42, 56, 84 and 91 | Baseline, Day 7, 14, 21, 28, 42, 56, 84, 91 | Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Here, n signifies those participants who were evaluable at specified time point for each arm, respectively. | millimeter of mercury (mmHg) | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Heart Rate Day 7, 14, 21, 28, 42, 56, 84 and 91 | Baseline, Day 7, 14, 21, 28, 42, 56, 84, 91 | Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Here, n signifies those participants who were evaluable at specified time point for each arm, respectively. | beats per minute | 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.
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