Rheumatoid arthritis
Conditions
Interventions
Adalimumab 40mg subcutaneously 1x/2 weeks.
Sponsors
AMC, Division of Clinical Immunology & Rheumatology
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with the diagnosis rheumatoid arthritis according to the American Rheumatism Association (ARA) 1987 criteria and in 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. DAS 28 => 3.2; 4. Age 18 - 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 <= 10 mg/day rovided that the dosage has been stable for at least 2 months prior to entry.
Exclusion criteria
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 intraarticular corticoid injections; b. Oral corticosteroid therapy exceeding a prednisone equivalent of 10 mg daily; c. Present use of DMARDs other than methotrexate; 7. Receipt of any live (attenuated) vaccines within 4 weeks prior to baseline; 8. Fever (orally measured > 38 ¢XC), 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 NYHA classification); 12. Progressive fatal disease/terminal illness; 13. A congenital or acquired (known 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 109/l; 16. Platelet count less than 100 x 109/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, metabolize 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints: 1. Clinical efficacy according to the EULAR response criteria at week 16 after initiation of treatment; 2. Exploration of clinical and serological markers that might distinguish responding from non-responding patients (e.g. the influence of anti-adalimumab antibody formation and adalimumab concentrations on response). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary endpoints 1. Clinical efficacy according to the EULAR response criteria at week 40 and 52 after initiation of treatment; 2. Exploration of genetic markers (e.g. cytokine polymorphisms) that are associated with clinical efficacy; 3. The effects of adalimumab on bonemineraldensity as measured by DEXA scanning; 4. The effects of adalimumab on lipidmetabolism as measured by fasting serum lipidprofiles in time; 5. The effects of adalimumab on workproductivity and sickleave measured by workrelated questionnaires during 52 weeks follow-up. | — |
Contacts
Public ContactC.A. Wijbrandts
Academic Medical Center (AMC), Department of Medicine, Division of Clinical Immunology and Rheumatology, F4-218, P.O. Box 22660
Outcome results
None listed