Trial · NCT01646385
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by mean follow-up in years). Crude (unadjusted) incidence rate calculated as number of malignancy events divided by Participant-Year, multiplied by 1000. |
| 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 | Participant-Year estimated by calculating all of years that participants in a study were followed (number of evaluable participants multiplied by mean follow-up in years). Crude (unadjusted) incidence rate calculated as number of LMs divided by Participant-Year, multiplied by 1000. Lymphoproliferative: medical condition characterized by the dysfunction of the immune system often resulting in excessive production of lymphocytes. LMs included lymphoma, myeloma, and leukemia. Adverse outcome was defined as 'lymphoproliferative malignancy' in the field \[lymphopro\] labeled by BSRBR. |
| 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 | Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by total follow-up in years). Crude (unadjusted) incidence rate calculated as number of serious infections divided by Participant-Year, multiplied by 1000. Serious infections included those infections which required intravenous antibiotics, hospitalization, or resulted in death. Adverse outcome was defined as 'serious infection' in the field \[serinf\] labeled by BSRBR. |
| 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 | Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by total follow-up in years). Crude (unadjusted) incidence rate calculated as number of other serious adverse events divided by Participant-Year, multiplied by 1000. Other serious adverse events were based on classifications assigned by the BSRBR and included cardiac serious adverse events (SAEs), central nervous system SAEs, and nonmalignant hematological SAEs. |
| 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 | Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by total follow-up in years). Crude (unadjusted) incidence rate calculated as number of deaths divided by Participant-Year, multiplied by 1000. Death was recorded in the adverse outcomes table and in the consultant follow-up table. Where multiple events described death for the same participant, date of death was taken as per the earliest record. |
| 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 | Participants who switched from etanercept to either DMARDs or alternative biologic drug are reported. |
| 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 | Time on etanercept therapy was calculated by Kaplan-Meier survival analysis. |
| Secondary | Disease Activity Score Based on 28-Joints Count (DAS28) at Baseline | Baseline | DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the serological markers of inflammation (erythrocyte sedimentation rate \[ESR, millimeter per hour\] or C-reactive protein \[CRP, milligram per liter\]) and patient's general health assessment (recorded on a Visual Analog Scale \[VAS\] of 0 millimeter \[mm\]-100 mm). DAS28 \<=1.6 = remission, DAS28 \<=2.4 = low disease activity, DAS28 \>=3.2 to 5.1 = moderate disease activity, DAS28 \>5.1 = severe disease activity. |
| 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 | DAS28 calculated from SJC and TJC using the 28 joints count, the serological markers of inflammation (ESR \[millimeter per hour\] or CRP \[milligram per liter\]) and patient's general health assessment (recorded on a VAS scale of 0 mm-100 mm). DAS28 \<=1.6 = remission, DAS28 \<=2.4 = low disease activity, DAS28 \>=3.2 to 5.1 = moderate disease activity, DAS28 \>5.1 = severe disease activity. |
| 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 | DAS28 calculated from SJC and TJC using the 28 joints count, the serological markers of inflammation (ESR \[millimeter per hour\] or CRP \[milligram per liter\]) and patient's general health assessment (recorded on a VAS scale of 0 mm-100 mm). DAS28 \<=1.6 = remission, DAS28 \<=2.4 = low disease activity, DAS28 \>=3.2 to 5.1 = moderate disease activity, DAS28 \>5.1 = severe disease activity. |
| 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 | DAS28 calculated from SJC and TJC using the 28 joints count, the serological markers of inflammation (ESR \[millimeter per hour\] or CRP \[milligram per liter\]) and patient's general health assessment (recorded on a VAS scale of 0 mm-100 mm). DAS28 \<=1.6 = remission, DAS28 \<=2.4 = low disease activity, DAS28 \>=3.2 to 5.1 = moderate disease activity, DAS28 \>5.1 = severe disease activity. Time to achieve remission was calculated by Kaplan-Meier survival analysis. |
| Secondary | Health Assessment Questionnaire (HAQ) Score at Baseline | Baseline | HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. |
| Secondary | Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Year 1, 2, and 3 | Baseline, Year 1, 2, 3 | HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. |
| Secondary | Percentage of Participants With Remission Based on Health Assessment Questionnaire (HAQ) Score | Year 1, 2, 3 | HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3. Participants who had HAQ total score \<=0.5 were considered in remission state. |
| 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 | HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. |
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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