Prospective study on the effects of adalimumab treatment in
patients with rheumatoid arthritis.

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.

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.