Humira in Rheumatoid Arthritis - Do Bone Erosions Heal?

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hvidovre University Hospital
• Collaborator: Abbott
• Treatments: Adalimumab

Criteria

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