Phase 4
Completed N=379
Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis.
Source: ClinicalTrials.gov NCT01172639 ↗Enrolled (actual)
379
Serious AEs
19.8%
Results posted
Dec 2018
Primary outcomePrimary: Remission According to DAS28-CRP at Week 16 — 69; 72; 61; 25 Participants
◆ Published Evidence
Highly cited
128citations · ~12 / year
Methotrexate in combination with other DMARDs is not superior to methotrexate alone for remission induction with moderate-to-high-dose glucocorticoid bridging in early rheumatoid arthritis after 16 weeks of treatment: the CareRA trial.
Summary
The Combinatietherapie Bij Reumatoide Artritis (CoBRA) trial was a milestone in the development of the present treatment paradigm for Rheumatoid Arthritis (RA). This study introduced the principle of fast remission induction by means of a combination of standard Disease Modifying AntiRheumatic Drugs (DMARDs) and a step down bridge therapy with high dose glucocorticoids in early Rheumatoid Arthritis.
The purpose of the present study is to compare different combinations of traditional DMARDs and glucocorticoids, based on the original CoBRA protocol, for treatment of early Rheumatoid Arthritis.
Besides the efficacy and effectiveness of these strategies, patient centered outcomes and potential implementation problems of such treatment strategies are evaluated.
Linked Publications (5)
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Methotrexate in combination with other DMARDs is not superior to methotrexate alone for remission induction with moderate-to-high-dose glucocorticoid bridging in early rheumatoid arthritis after 16 weeks of treatment: the CareRA trial.
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Effectiveness of methotrexate with step-down glucocorticoid remission induction (COBRA Slim) versus other intensive treatment strategies for early rheumatoid arthritis in a treat-to-target approach: 1-year results of CareRA, a randomised pragmatic open-label superiority trial.
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Patients lacking classical poor prognostic markers might also benefit from a step-down glucocorticoid bridging scheme in early rheumatoid arthritis: week 16 results from the randomized multicenter CareRA trial.
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Having a co-morbidity predicts worse outcome in early rheumatoid arthritis despite intensive treatment: a post hoc evaluation of the pragmatic randomized controlled CareRA trial.
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Short-term glucocorticoids reduce risk of chronic NSAID and analgesic use in early methotrexate-treated rheumatoid arthritis patients with favourable prognosis: subanalysis of the CareRA randomised controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Remission According to DAS28-CRP at Week 16 |
69; 72; 61; 25; 23 | — |
| PRIMARY Remission According to DAS28-CRP at Week 52 |
63; 57; 57; 29; 29 | — |
| PRIMARY Remission According to DAS28-CRP at Week 104 |
64; 71; 69; 29; 34 | — |
| SECONDARY Remission According to SDAI (Simple Disease Activity Index) at Week 16 |
42; 33; 44; 12; 12 | — |
| SECONDARY Remission According to SDAI at Week 52 |
36; 27; 39; 20; 15 | — |
| SECONDARY Remission According to SDAI at Week 104 |
31; 28; 41; 20; 13 | — |
| SECONDARY Clinically Significant Change in HAQ Score |
71; 62; 64; 25; 26 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of RA as defined by the 1987 or 2010 revised American College of Rheumatology (ACR) criteria
- Early RA (less than 1 year)
- Use a reliable method of contraception for women of childbearing potential
- Able and willing to give written informed consent and participate in the study
Exclusion Criteria
- Previous treatment with DMARDs
- Previous treatment with oral corticosteroids at a dosage of more than 10 milligrams (mg) prednisone within 4 weeks before baseline
- Previous treatment with oral corticosteroids at a dosage equal to or less than 10 mg prednisone within 2 weeks before baseline
- Previous treatment with oral corticosteroids for more than 4 weeks
- Previous treatment with Intra Articular corticosteroids within 4 weeks before baseline
- Previous treatment with an investigational drug for the treatment or prevention of RA
- Contraindications for corticosteroids
- Contraindications for DMARDs
- Psoriatic Arthritis
- Underlying cardiac, pulmonary, metabolic, renal or gastrointestinal conditions, chronic or latent infectious diseases or immune deficiency which in the opinion of the investigator places the patient at an unacceptable risk for participation in the study
- Pregnancy, breastfeeding or no use of a reliable method of contraception
- Alcohol or drug abuse
Data sourced from ClinicalTrials.gov (NCT01172639) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.