A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, EFFICACY STUDY OF APREMILAST (CC-10004) IN SUBJECTS WITH EROSIVE HAND OSTEOARTHRITIS - Apremilast CC-10004 in Osteoarthritis

Med. Fakultaet der Friedrich-Alexander Universitaet Erlangen-Nuernberg0 个研究点开始时间: 2009年12月3日最近更新: 2014年12月1日

适应症

试验速览

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•- Must understand and voluntarily sign an informed consent form including written consent for data protection
•- Must be male or female and aged = 18 years at time of consent
•- Must have a diagnosis of erosive hand osteoarthritis according to ACR criteria for at least six months
•- Must have at least two bone erosions detectable in conventional radiographs of the hands at the first carpo-metacarpal joint (CMC), proximal and/or distal interphalangeal joints
•- Must have active disease at screening and randomization with at least two swollen and tender PIP and/or DIP joints; with the same two joints affected at both screening and randomization.
•- Must have a patients self assessment of pain at baseline of at least 40% on a VAS
•- Must have negative rheumatoid factor (RF) and anti-CCPantibody
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- History of any clinically significant inflammatory disease other than EHOA, especially, but not limited to, rheumatoid arthritis or spondylarthropathies
•- History or Diagnosis of Fibromyalgia
•- Any injury, medical or surgical procedure to the affected joint(s) that may interfere with evaluation of the target hand OA joint(s)
•- Pregnant or lactating female
•- History of active Mycobacterium tuberculosis infection within 3 years prior to the screening visit. Infections that occurred > 3 years prior to entry must have been effectively treated
•- Any anti-inflammatory or immunosuppressive therapy for any condition including, but not limited to, glucocorticoids, methotrexate, sulfasalazine, leflunomide, chloroquine, hydroxychloroquine, gold compounds, parenteral corticosteroids, penicillamine, cyclosporine, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, tacrolimus and azathioprine within 35 days of randomization and throughout the study
•- Use of NSAIDs within 35 days of randomization and throughout the study
•- Have a known history of serious infections (eg, hepatitis, pneumonia, or pyelonephritis) in the previous 3 months

发起方

Med. Fakultaet der Friedrich-Alexander Universitaet Erlangen-Nuernberg