Status:
COMPLETED
Humira in Rheumatoid Arthritis - Do Bone Erosions Heal?
Lead Sponsor:
Hvidovre University Hospital
Collaborating Sponsors:
Abbott
Conditions:
Rheumatoid Arthritis
Arthritis
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief 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...
Detailed Description
Studies on tumor necrosis factor alpha antagonist (anti-TNF) therapy in rheumatoid arthritis (RA) patients have found that radiographic erosions scores decreased in some patients. This suggests that e...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00696059
Start Date
August 1 2004
End Date
July 1 2007
Last Update
June 12 2008
Active Locations (5)
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1
Department of Rheumatology, Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark, DK-2100
2
Department of Rheumatology, Bispebjerg University Hospital
Copenhagen, Denmark, DK-2400
3
Department of Rheumatology, Gentofte University Hospital
Hellerup, Denmark, DK-2900
4
Department of Rheumatology, Herlev University Hospital
Herlev, Denmark, DK-2630