Trial · NCT01623752
Registered outcomes39
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 39
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | To assess radiological damage mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively. |
| 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 | To assess radiological damage, mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively. |
| 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 | To assess radiological damage, mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively. |
| 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 | To assess radiological damage, mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively. |
| 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 | The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (greater than \[\>\] 0.5), no change (-0.5 to 0.5) and decrease (less than \[\<\] -0.5). Participants with no change or a decrease were considered to be in radiographic remission. |
| 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 | The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (\>0.5), no change (-0.5 to 0.5) and decrease (\<-0.5). Participants with no change or a decrease were considered to be in radiographic remission. |
| 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 | The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (\>0.5), no change (-0.5 to 0.5) and decrease (\<-0.5). Participants with no change or a decrease were considered to be in radiographic remission. |
| 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 | The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (\>0.5), no change (-0.5 to 0.5) and decrease (\<-0.5). Participants with no change or a decrease were considered to be in radiographic remission. |
| Secondary | Linear Relationship Between Normalized Radiographic Progression and Disease Duration | Baseline up to Week 78 | Linear relationship between radiographic progression and disease duration was evaluated using a linear regression model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was disease duration. |
| 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 | Effect on normalized radiographic progression with respect to ACPA-RF was evaluated using an analysis of variance (ANOVA) model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was groups of positive testing of ACPA and RF at baseline. |
| Secondary | Effect on Normalized Radiographic Progression With Respect to Baseline Usage of Concomitant Medication | Baseline up to Week 78 | Effect on normalized radiographic progression with respect to use of concomitant medication at baseline was evaluated using an ANOVA model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was groups of concomitant medication as found among the medication given concomitantly during study that is recorded at baseline. |
| Secondary | Effect on Normalized Radiographic Progression With Respect to Previous Treatment With Biologics | Baseline up to Week 78 | Effect on normalized radiographic progression of previous treatment with biologics was evaluated using an ANOVA model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was previous treatment with biologics. |
| Secondary | Effect on Normalized Radiographic Progression With Respect to Baseline Disease Activity Score-28 (DAS-28) | Baseline up to Week 78 | Effect on radiographic progression with respect to baseline DAS-28 was evaluated using ANOVA model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was baseline DAS-28. Baseline DAS-28 is less than or equal to (\<=) 5.1 or \>5.1. DAS28: score range from 0 (none) to 9.4 (extreme disease activity); low =2.6 to 3.2, moderate =3.2 to 5.1, and high disease activity \>5.1. DAS28 score of \<2.6 indicates disease remission. |
| Secondary | Change From Baseline in Total Erosion Score at End of Phase 1 (Week 78) and Phase 2 (Week 156) | Baseline, Week 78, 156 | Total erosion score as per van der Hejde method consisted of 2 dimensions: a) hands (32 erosion locations, each location graded from 0 \[no erosion\] to 5 \[maximum severity\], sum of grading of each location resulted in score of 0 to 160); and b) feet (12 erosion locations, each location graded from 0 \[no erosion\] to 10 \[maximum severity\], sum of grading of each location resulted in score of 0 to 120). Sum of erosion scores of hand (0 to 160) and feet (0 to 120) gave a total erosion score as 0 to 280, where 0 was no erosion at all and 280 was worst possible condition, higher scores indicated severe joint destruction. |
| 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 | Total joint space narrow score as per van der Hejde method consisted of 2 dimensions: a) hands (30 joint space locations, each location graded from 0 \[normal joint space\] to 4 \[bony ankylosis\], sum of grading of each location resulted in score of 0 to 120); and b) feet (12 erosion locations, each location graded from 0 \[no erosion\] to 4 \[bony ankylosis\], sum of grading of each location resulted in score of 0 to 48). Sum of joint space narrow scores of hand (0 to 120) and feet (0 to 48) gave a total joint space narrow score as 0 to 168, where 0 was normal joint space and 168 was maximum narrowing in joints, higher scores indicated severe joint destruction. |
| 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 | FFbH is a self-administered patient questionnaire composed by 18 questions on functional ability in activities of daily living. Each question was answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned =2), "Yes, but with difficulties" (score assigned =1) and "No or only with external help" (score assigned =0). Final FFbH score (%) was then computed according to formula: (Sum of scores\*100) divided by (2\*number of valid answers), ranging between 0 (no functional capacity) to 100 (full functional capacity); higher scores indicate better daily activities. FFbH functional remission was defined as FFbH functional capacity of \>= 83%. |
| 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 | DAS28 was calculated from swollen joint count and tender joint count using 28 joint count, C-reactive protein (CRP) in milligram per liter (mg/L) and participant global assessment (PtGA) of disease activity measured on a 100 mm visual analog scale (VAS) ranging from 0 (good condition) to 100 (worst condition), where higher scores indicate worse health condition). DAS28 total score range: 0 (no disease activity) to 9.4 (maximum disease activity), higher score indicates more disease activity. DAS-28 score of 2.6 to 3.2= low, 3.2 to 5.1= moderate and \>5.1= high disease activity. DAS-28 score of \<2.6= disease remission. DAS28-4(CRP) = (0.56\*sqrt\[TJC28\] + 0.28\*sqrt\[SJC28\] + 0.36\*ln\[CRP+1\]) + 0.014\*GH + 0.96) and DAS28-4(ESR) = (0.56\*sqrt\[TJC28\] + 0.28\*sqrt\[SJC28\] + 0.70\*ln\[ESR\] + 0.014\*GH), where sqrt = square root, ln = natural logarithm. |
| 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 | CDAI was calculated from tender and swollen joints using 28 joint count, participant global assessment (PtGA) and physician global assessment (PhyGA). PtGA and PhyGA both were assessed on 0-100 mm VAS scale, where higher scores indicated greater affection due to disease activity. CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of \<=10 indicates low disease activity and a score of \<= 2.8 indicates remission. |
| 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 | SDAI was calculated from tender and swollen joints using 28 joint count, participant global assessment (PtGA), physician global assessment and (PhyGA) and CRP (in mg/L). PtGA and PhyGA both were assessed on 0-100 mm VAS scale, where higher scores indicated greater affection due to disease activity. SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of \<=11 indicates low disease activity and a score of \<=3.3 indicates remission. |
| 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 | CDAI was calculated from tender and swollen joints using 28 joint count, PtGA and PhyGA. CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of \<=10 indicates low disease activity and a score of \<= 2.8 indicates remission. SDAI was calculated from tender and swollen joints using 28 joint count, PtGA, PhyGA and CRP (in mg/L). SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of \<=11 indicates low disease activity and a score of \<=3.3 indicates remission. PtGA and PhyGA both were assessed on 0-100 mm VAS scale, where higher scores indicated greater affection due to disease activity. |
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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