Rheumatoid Arthritis Clinical Trial
— HURRAHOfficial title:
Can Bone Erosions Heal in Adalimumab (Humira) Treated Rheumatoid Arthritis Patients. An Imaging Study Using Computed Tomography and Magnetic Resonance Imaging.
Studies on tumor necrosis factor alpha antagonist (anti-TNF) therapy in rheumatoid arthritis (RA) patients have found that erosive damage may "heal" in some RA patients treated with anti-TNF. Repeated examinations of adalimumab (Humira) treated RA patients, using computed tomography (CT), magnetic resonance imaging (MRI), ultrasonography (US) and radiography will allow detailed assessment of the extent of bone repair/healing during adalimumab (Humira) therapy.
Status | Completed |
Enrollment | 52 |
Est. completion date | July 2007 |
Est. primary completion date | July 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of rheumatoid arthritis according to the American College of Rheumatology 1987 criteria - Moderate or severely active RA, defined as a DAS28(CRP)> 3.2 - Moderate radiographic structural joint damage, defined as Larsen grade 2-3, in = 2 wrist and/or MCP joints - No previous biological therapy - Clinical indication for biological therapy, according to the treating physician - Treatment with methotrexate and folic acid for at least 4 weeks prior to inclusion - No history of tuberculosis, and no signs of tuberculosis at chest radiograph or Mantoux test. - No contra-indications for TNF-alpha antagonist treatment - Co-operability of the patient, including that the patient is willing and able to comply with the treatment and scheduled follow-up visits and examinations - Oral and signed informed consent by the patient Exclusion Criteria: - Acute infection, and known chronic viral infection such as HIV or hepatitis B and C - Other DMARDs than methotrexate within last 4 weeks before inclusion - Intramuscular or intraarticular glucocorticoids within last 4 weeks before inclusion - Oral treatment with prednisolone >10 mg per day - Malignant lymphoma and other malignant disease - Other serious concomitant diseases (uncontrolled/severe kidney, liver, haematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological or cerebral disease (including demyelinating disease)) - Pregnancy and lactation. Patients must use safe anti-conception during the treatment. - Development of SLE-like disease. Occurrence of positive ANA and/or anti-DNA antibodies without clinical symptoms is not considered a contra-indication. - Contra-indications for MRI |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Rheumatology, Bispebjerg University Hospital | Copenhagen | |
Denmark | Department of Rheumatology, Copenhagen University Hospital, Rigshospitalet | Copenhagen | |
Denmark | Department of Rheumatology, Gentofte University Hospital | Hellerup | |
Denmark | Department of Rheumatology, Herlev University Hospital | Herlev | |
Denmark | Department of Rheumatology, Hvidovre University Hospital | Hvidovre |
Lead Sponsor | Collaborator |
---|---|
Hvidovre University Hospital | Abbott |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | By means of computed tomography and magnetic resonance imaging to investigate if repair of bone erosion occurs in rheumatoid arthritis joints during adalimumab (Humira) therapy | 52 weeks | No |
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