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The first double-blind, randomised, parallel-group certolizumab pegol study in methotrexate-naive early rheumatoid arthritis patients with poor prognostic factors, C-OPERA, shows inhibition of radiographic progression
- Source :
- Annals of the Rheumatic Diseases, Annals of the Rheumatic Diseases, 75(1), 75-83
- Publication Year :
- 2015
- Publisher :
- BMJ, 2015.
-
Abstract
- Objectives To evaluate efficacy and safety of combination therapy using certolizumab pegol (CZP) and methotrexate (MTX) as first-line treatment for MTX-naive, early rheumatoid arthritis (RA) with poor prognostic factors, compared with MTX alone. Methods MTX-naive, early RA patients with ≤12 months persistent disease, high anti-cyclic citrullinated peptide, and either rheumatoid factor positive and/or presence of bone erosions were enrolled in this multicentre, double-blind, randomised placebo (PBO)-controlled study. Patients were randomised 1:1 to CZP+MTX or PBO+MTX for 52 weeks. Primary endpoint was inhibition of radiographic progression (change from baseline in modified Total Sharp Score (mTSS CFB)) at week 52. Secondary endpoints were mTSS CFB at week 24, and clinical remission rates at weeks 24 and 52. Results 316 patients randomised to CZP+MTX (n=159) or PBO+MTX (n=157) had comparable baseline characteristics reflecting features of early RA (mean disease duration: 4.0 vs 4.3 months; Disease Activity Score 28-joint assessment (DAS28)) (erythrocyte sedimentation rate (ESR)): 5.4 vs 5.5; mTSS: 5.2 vs 6.0). CZP+MTX group showed significantly greater inhibition of radiographic progression relative to PBO+MTX at week 52 (mTSS CFB=0.36 vs 1.58; p
- Subjects :
- Male
Radiography
Severity of Illness Index
Gastroenterology
Anti-TNF
Arthritis, Rheumatoid
0302 clinical medicine
Early Rheumatoid Arthritis
Clinical endpoint
Immunology and Allergy
030212 general & internal medicine
Certolizumab pegol
skin and connective tissue diseases
medicine.diagnostic_test
Remission Induction
Middle Aged
Prognosis
Treatment Outcome
Antirheumatic Agents
Erythrocyte sedimentation rate
Drug Therapy, Combination
Female
medicine.drug
Adult
musculoskeletal diseases
medicine.medical_specialty
Combination therapy
Immunology
Rheumatoid Arthritis
Blood Sedimentation
Placebo
Peptides, Cyclic
Antibodies
General Biochemistry, Genetics and Molecular Biology
03 medical and health sciences
Double-Blind Method
Rheumatology
Rheumatoid Factor
Internal medicine
medicine
Humans
Rheumatoid factor
Disease Activity
Inflammation
030203 arthritis & rheumatology
business.industry
Clinical and Epidemiological Research
Surgery
Methotrexate
Certolizumab Pegol
business
Subjects
Details
- ISSN :
- 14682060 and 00034967
- Volume :
- 75
- Database :
- OpenAIRE
- Journal :
- Annals of the Rheumatic Diseases
- Accession number :
- edsair.doi.dedup.....59f637ce3eb2c1d31350373aac25b5ec
- Full Text :
- https://doi.org/10.1136/annrheumdis-2015-207511