Trial · NCT01646385
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Crude Incidence Rate of Malignancy | Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years | Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration. | events per 1000 participant-years | NUMBER |
| PRIMARY | Crude Incidence Rate of Lymphoproliferative Malignancy (LM) | Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years | Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration. | events per 1000 participant-years | NUMBER |
| PRIMARY | Crude Incidence Rate of Serious Infections | Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years | Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration. | events per 1000 participant-years | NUMBER |
| PRIMARY | Crude Incidence Rate of Other Serious Adverse Events | Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years | Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration. | events per 1000 participant-years | NUMBER |
| PRIMARY | Crude Incidence Rate of All-Cause Mortality | Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years | Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration. | events per 1000 participant-years | NUMBER |
| SECONDARY | Percentage of Participants Who Switched to Other Therapy Following Etanercept Discontinuation | Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years | Full Analysis set (FAS) population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration. Only participants treated with ETN were to be analyzed for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Time on Etanercept Therapy | Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years | FAS population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration. Only participants treated with ETN were to be analyzed for this outcome measure. | years | MEDIAN |
| SECONDARY | Disease Activity Score Based on 28-Joints Count (DAS28) at Baseline | Baseline | FAS population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Disease Activity Score Based on 28-Joints Count (DAS28) at Year 1, 2, 3, 4, and 5 | Baseline, Year 1, 2, 3, 4, 5 | FAS included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of 1 consultant follow-up after baseline registration. N (number of participants analyzed): participants evaluable for this measure, n: participants evaluable for specified time-points for each treatment arm, respectively. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Remission and Low Disease Activity as Assessed by Disease Activity Score Based on 28-Joints Count (DAS28) | Year 1, 2, 3, 4, 5 | FAS included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of 1 consultant follow-up after baseline registration. N (number of participants analyzed): participants evaluable for this measure, n: participants evaluable for specified time-points for each treatment arm, respectively. | percentage of participants | NUMBER |
| SECONDARY | Time to Remission | Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years | FAS population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration. | years | MEDIAN |
| SECONDARY | Health Assessment Questionnaire (HAQ) Score at Baseline | Baseline | FAS population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Year 1, 2, and 3 | Baseline, Year 1, 2, 3 | FAS included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of 1 consultant follow-up after baseline registration. N (number of participants analyzed): participants evaluable for this measure, n: participants evaluable for specified time-points for each treatment arm, respectively. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Remission Based on Health Assessment Questionnaire (HAQ) Score | Year 1, 2, 3 | FAS included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of 1 consultant follow-up after baseline registration. N (number of participants analyzed): participants evaluable for this measure, n: participants evaluable for specified time-points for each treatment arm, respectively. | percentage of participants | NUMBER |
| SECONDARY | Health Assessment Questionnaire (HAQ) Score 6 Months Prior to And 6 Months Post-Switching Etanercept | 6 months prior to and 6 months post switching etanercept | FAS population. Here N (number of participants analyzed): participants evaluable for this measure, n: participants evaluable for specified time-points. Only participants treated with ETN were to be analyzed for this outcome measure. | units on a scale | 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
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GET https://conductscience.org/api/trials/v1/NCT01646385/outcomes