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RCT part: CareRA2020: Effectiveness of a combination of Methotrexate and a step down glucocorticoid regimen (COBRA-Slim) for remission induction in patients with early Rheumatoid Arthritis (RA), with or without fast access to 24 weeks of Tumor Necrosis Factor (TNF) blockade in insufficient responders, a randomized, multicenter, pragmatic trial. LTE part: CareRA2020 LTE: a 3 year longitudinal observational, multicenter, follow-up of early RA patients after participation in the CareRA2020 RCT.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-510189-28-00
Acronym
S59474; KCE-16002
Enrollment
442
Registered
2024-02-01
Start date
2018-05-15
Completion date
2025-07-08
Last updated
2024-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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

UZ Leuven
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026