Rheumatoid Arthritis
Conditions
Brief summary
For the RCT part: Area under the curve of DAS28CRP over 104 weeks (long term effectiveness) in insufficient responders randomized to either COBRA-Slim Bio-Induction or Standard COBRA-Slim Induction., For the LTE part: Area under the curve of DAS28-CRP over 260 weeks (long term effectiveness) in insufficient responders randomized to either COBRA-Slim Bio-Induction or Standard COBRA-Slim Induction.
Detailed description
For the RCT part: Proportion of insufficient responders achieving remission (DAS28CRP<2.6) 28 weeks after randomization (short term efficacy) to either COBRA-Slim Bio-Induction or Standard COBRA-Slim Induction., For the RCT part: 1. Clinical efficacy: Remission (DAS28CRP<2.6) at w104, EULAR response at 28 weeks after randomization and at w104, HAQ response at 28 weeks after randomization and at w104; 2. Radiographic progression: X-ray evolution at w52 and w104 compared to BL as reviewed and evaluated by the central team; 3. Side effects: (S)ARs from BL until w104; 4. To evaluate the primary outcome using the DAS28ESR instead of the DAS28CRP., For the LTE part: 1. To further determine the clinical efficacy of the accelerated access to Etanercept strategy versus the classic COBRA Slim strategy; 2. To evaluate the safety of the given treatments.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For the RCT part: Area under the curve of DAS28CRP over 104 weeks (long term effectiveness) in insufficient responders randomized to either COBRA-Slim Bio-Induction or Standard COBRA-Slim Induction., For the LTE part: Area under the curve of DAS28-CRP over 260 weeks (long term effectiveness) in insufficient responders randomized to either COBRA-Slim Bio-Induction or Standard COBRA-Slim Induction. | — |
Secondary
| Measure | Time frame |
|---|---|
| For the RCT part: Proportion of insufficient responders achieving remission (DAS28CRP<2.6) 28 weeks after randomization (short term efficacy) to either COBRA-Slim Bio-Induction or Standard COBRA-Slim Induction., For the RCT part: 1. Clinical efficacy: Remission (DAS28CRP<2.6) at w104, EULAR response at 28 weeks after randomization and at w104, HAQ response at 28 weeks after randomization and at w104; 2. Radiographic progression: X-ray evolution at w52 and w104 compared to BL as reviewed and evaluated by the central team; 3. Side effects: (S)ARs from BL until w104; 4. To evaluate the primary outcome using the DAS28ESR instead of the DAS28CRP., For the LTE part: 1. To further determine the clinical efficacy of the accelerated access to Etanercept strategy versus the classic COBRA Slim strategy; 2. To evaluate the safety of the given treatments. | — |
Countries
Belgium