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Rheumatoid Arthritis Treatment and Biopsy Study Assessing Certolizumab Pegol (Cimzia)
Bu çalışma, romatoid artrit (rheumatoid arthritis) olan hastalarda Certolizumab Pegol tedavisini ve eklem dokusundan alınan biyopsileri değerlendirmiştir. Çalışmaya 18 yaş üstü, ACR ölçütlerine göre tanı almış ve en az 12 haftadır Metotreksat kullanan, hastalığı aktif olan hastalar alınmıştır. Faz 3 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: * Signed and dated informed consent document * Subjects must be at least 18 years of age or older * Subject must be willing and able to comply with scheduled visits, arthroscopy, laboratory tests, and other procedures * Diagnosis of RA based on American College of Rheumatology (ACR) 1987 Revised Criteria * Active disease at screening visit * Methotrexate taken continuously for at least 12 weeks at a stable dosage * Sexually active women of child-bearing potential and men whose partners are women of child-bearing potential are required to use adequate contraceptive methods during participation on this trial * Treatment with non-steroidal anti-inflammatory drugs (NSAIDS)and oral corticosteroids (less than or equal to 10 mg/day prednisone or equivalent)is accepted Exclusion Criteria: * Diagnosis of any other inflammatory arthritis * History of infected joint prosthesis that is still in situ * History of allergy to local anesthetic agents * Pregnant or lactating women * Current or recent history of uncontrolled clinically significant conditions(e.g..,kidney disease, liver disease, class III or IV congestive heart failure, according to the New York Heart Association) * History or suspected demyelinating disease of the central nervous system, e.g. multiple sclerosis or optic neuritis * Current participation in clinical trial