Trial · NCT01623752
Outcomes39
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 39
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Van Der Heijde Total Modified Total Sharp Score (mTSS) or Adapted mTSS at End of Phase 1 (Week 78): Efficacy Analysis Set (EAS) | Baseline, Week 78 | Efficacy analysis set for Phase 1= all participants who had received at least 1 dose of Etanercept and had baseline X-ray (Rx1) and end of phase 1 X-ray (Rx2). Here, Overall Number of Participants Analyzed =number of participants evaluable for this outcome measure; Number Analyzed=number of participants evaluable for the specified time points. | Units on a scale | MEAN |
| PRIMARY | Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 1 (Week 78): Completer Analysis Set (CAS) | Baseline, Week 78 | Completer analysis set for Phase 1: all participants who had received at least 1 dose of Etanercept and had clinical data for Rx1 and Rx2 and provided data for end of Phase 1 of study. Overall Number of Participants Analyzed = participants evaluable for this outcome measure. Number Analyzed= participants evaluable for the specified time points. | Units on a scale | MEAN |
| PRIMARY | Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at the End of Phase 2 (Week 156): EAS | Baseline, Week 156 | Efficacy analysis set for Phase 2 included all participants who had received at least 1 dose of Etanercept and had Rx1 and end of Phase 2 X-ray (Rx3). Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure. | Units on a scale | MEAN |
| PRIMARY | Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 2 (Week 156): CAS | Baseline, Week 156 | Completer analysis set for Phase 2 included all participants who had received at least 1 dose of Etanercept, and had clinical data for the obligatory X-ray (Rx1) and Rx3, and completed Phase 2 of the study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure. | Units on a scale | MEAN |
| PRIMARY | Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): EAS | Pre-treatment, Week 78 | Efficacy analysis set for Phase 1 included all participants who had received at least 1 dose of Etanercept and had Rx1 and Rx2. Here, Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure and Number Analyzed = number of participants evaluable for the specified time points. | Scores per year | MEAN |
| PRIMARY | Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): CAS | Pre-treatment, Week 78 | CAS for phase 1 included all participants who had received at least 1 dose of Etanercept, and had Rx1 and Rx2, and provided data for end of Phase 1 of study. Here, Overall Number of Participants Analyzed=number of participants evaluable for this outcome measure and Number Analyzed=number of participants evaluable for the specified time points. | Scores per year | MEAN |
| PRIMARY | Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 2 (Week 156): EAS | Pre-treatment, Week 156 | Efficacy analysis set for Phase 2 included all participants who had received at least 1 dose of Etanercept and had Rx1 and Rx3. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure. | Scores per year | MEAN |
| PRIMARY | Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at the End of Phase 2 (Week 156): CAS | Pre-treatment, Week 156 | CAS for phase 2 included all participants who had received at least 1 dose of Etanercept, and had Rx1 and Rx2, and completed phase 2 of the study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure. | Scores per year | MEAN |
| SECONDARY | Linear Relationship Between Normalized Radiographic Progression and Disease Duration | Baseline up to Week 78 | Efficacy analysis set for Phase 1 included participants who received at least 1 dose of Etanercept and had Rx1 and Rx2. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure. | Regression coefficient | NUMBER |
| SECONDARY | Effect on Normalized Radiographic Progression With Respect to Baseline Positivity of Anti-citrullinated Protein Antibody (ACPA) - Rheumatoid Factor (RF) | Baseline up to Week 78 | Efficacy analysis set for Phase 1 included participants who received at least 1 dose of Etanercept and had Rx1 and Rx2. Here, Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure and Number Analyzed = number of participants evaluable for the specified rows. | Scores per year | LEAST_SQUARES_MEAN |
| SECONDARY | Effect on Normalized Radiographic Progression With Respect to Baseline Usage of Concomitant Medication | Baseline up to Week 78 | Efficacy analysis set for Phase 1 included participants who received at least 1 dose of Etanercept and had Rx1 and Rx2. Here, Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure and Number Analyzed = number of participants evaluable for the specified rows. | Scores per year | LEAST_SQUARES_MEAN |
| SECONDARY | Effect on Normalized Radiographic Progression With Respect to Previous Treatment With Biologics | Baseline up to Week 78 | Efficacy analysis set for Phase 1 included participants who received at least 1 dose of Etanercept and had Rx1 and Rx2. Here, Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure and Number Analyzed = number of participants evaluable for the specified rows. | Scores per year | LEAST_SQUARES_MEAN |
| SECONDARY | Effect on Normalized Radiographic Progression With Respect to Baseline Disease Activity Score-28 (DAS-28) | Baseline up to Week 78 | Efficacy analysis set for Phase 1 included participants who received at least 1 dose of Etanercept and had Rx1 and Rx2. Here, Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure and Number Analyzed = number of participants evaluable for the specified rows. | Scores per year | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Total Erosion Score at End of Phase 1 (Week 78) and Phase 2 (Week 156) | Baseline, Week 78, 156 | Efficacy analysis set included participants who received at least 1 dose of Etanercept and had Rx1 and Rx2 or had Rx1 and Rx3. Here, Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure and Number Analyzed = number of participants evaluable for the specified time points. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Total Joint Space Narrow Score at End of Phase 1 (Week 78) and Phase 2 (Week 156) | Baseline, Week 78, 156 | Efficacy analysis set included participants who received at least 1 dose of Etanercept and had Rx1 and Rx2 or have Rx1 and Rx3. Here, Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure and Number Analyzed = number of participants evaluable for the specified time points. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Hannover Functional Ability Questionnaire (FFbH) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 | Full analysis set included all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Here, Number Analyzed signifies number of participants evaluable for the specified time points. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Disease Activity Score-28 (DAS-28) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 | Full analysis set included all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Here, Number Analyzed signifies number of participants evaluable for the specified time points. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 | Full analysis set: all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Number Analyzed = number of participants evaluable for the specified time points. Data for this outcome measure was to be collected and evaluated only for participants with rheumatoid arthritis. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Simple Disease Activity Index (SDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 | Full analysis set: all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Number Analyzed = number of participants evaluable for the specified time points. Data for this outcome measure was to be collected and evaluated only for participants with rheumatoid arthritis. | Units on a scale | MEAN |
| SECONDARY | Percentage of Participants With Rheumatoid Arthritis, With Low Disease Activity Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 | Full analysis set: all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Number Analyzed = number of participants evaluable for the specified time points. Data for this outcome measure was to be collected and evaluated only for participants with rheumatoid arthritis. | 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.
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GET https://conductscience.org/api/trials/v1/NCT01623752/outcomes