Humira in Rheumatoid Arthritis - Do Bone Erosions Heal?

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00696059
• Date of registration: 09/06/2008
• Primary sponsor: Hvidovre University Hospital
• Public title: Humira in Rheumatoid Arthritis - Do Bone Erosions Heal? HURRAH
• Scientific title: Can Bone Erosions Heal in Adalimumab (Humira) Treated Rheumatoid Arthritis Patients. An Imaging Study Using Computed Tomography and Magnetic Resonance Imaging.
• Date of first enrolment: August 2004
• Target sample size: 52
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00696059
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Denmark

Contacts

• Name: Mikkel Østergaard, Professor
• Affiliation: Department of Rheumatology, Hvidovre University Hospital

• Name: Uffe Møller Døhn, M.D
• Affiliation: Department of Rheumatology, Hvidovre University Hospital

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 90 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Arthritis

Joint Diseases

Rheumatoid Arthritis

Intervention(s)

Drug: Adalimumab (Humira)

Primary Outcome(s)

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 [Time Frame: 52 weeks]

Secondary ID(s)

HUM 04-20

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Abbott