Overview

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