ISRCTN68762628CompletedNot Applicable
Prospective study on the effects of adalimumab treatment in patients with rheumatoid arthritis
Academic Medical Center (AMC) (The Netherlands)0 sites50 target enrollmentStarted: January 22, 2007Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1. Patients with the diagnosis rheumatoid arthritis according to the American Rheumatism Association (ARA) 1987 criteria and in American College of Rheumatology (ACR) 1991 functional classes I, II, and III
- •2. The patient is naÏve for anti-TNF-alpha therapy or has failed other prior TNF-alpha blockers
- •3. Disease Activity Score (DAS 28) more than or equal to 3.2
- •4. Age 18 to 85 years old
- •5. Use concurrent methotrexate treatment (5 - 30 mg/week stable since at least 28 days before initiation) during the study. Subjects may be taking nonsteroidal anti-
- •inflammatory drugs, provided the dose and frequency have been stable for at least 28 days. Subjects may be receiving prednisone therapy less than or equal to 10 mg/day rovided that the dosage has been stable for at least two months prior to entry
Exclusion Criteria
- •1. Pregnancy
- •2. Breastfeeding
- •3. A history of or current acute inflammatory joint disease of different origin e.g. mixed connective tissue disease, seronegative spondylarthropathy, psoriatic arthritis, Reiter's syndrome, systemic lupus erythematosus or any arthritis with onset prior to age 16 years
- •4. Acute major trauma
- •5. Therapy within the previous 60 days with:
- •a. any experimental drug
- •b. alkylating agents
- •c. antimetabolites
- •d. monoclonal antibodies (including infliximab and etanercept)
- •e. growth factors
- •f. other cytokines
- •6. Therapy within the previous 28 days with:
- •a. parenteral or intra-articular corticoid injections
- •b. oral corticosteroid therapy exceeding a prednisone equivalent of 10 mg daily
- •c. present use of Disease Modifying Anti-Rheumatic Drugs (DMARDs) other than methotrexate
- •7. Receipt of any live (attenuated) vaccines within four weeks prior to baseline
- •8. Fever (orally measured more than 38°C), chronic infections or infections requiring anti-microbial therapy
- •9. Known positive reaction to hepatitis B surface antigen or hepatitis C antigen
- •10. Other active medical conditions such as inflammatory bowel disease, bleeding diathesis, or severe unstable diabetes mellitus
- •11. Manifest cardiac failure (stage III or IV according to New York Heart Association [NYHA] classification)
- •12. Progressive fatal disease/terminal illness
- •13. A congenital or acquired (known Human Immunodeficiency Virus [HIV]-positive status) immunodeficiency
- •14. A history of lymphoproliferative disease or treatment with total lymphoid irradiation
- •15. A white cell count less than 3.5 x 10^9/l
- •16. Platelet count less than 100 x 10^9/l
- •17. Haemoglobin of less than 5.3 mmol/l
- •18. Body weight of less than 45 kg
- •19. History of drug or alcohol abuse
- •20. Any concomitant medical condition which would in the investigator's opinion compromise the patient's ability to tolerate, absorb, metabolise or excrete the study medication
- •21. Inability to give informed consent
- •22. Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study and/or evidence of an uncooperative attitude
Investigators
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