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

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoints:<br>1. Clinical efficacy according to the EULAR response criteria at week 16 after initiation of treatment;<br>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 Outcome Measures

Name	Time	Method
Secundary endpoints<br>1. Clinical efficacy according to the EULAR response criteria at week 40 and 52 after initiation of treatment;<br>2. Exploration of genetic markers (e.g. cytokine polymorphisms) that are associated with clinical efficacy; <br>3. The effects of adalimumab on bonemineraldensity as measured by DEXA scanning;<br>4. The effects of adalimumab on lipidmetabolism as measured by fasting serum lipidprofiles in time;<br>5. The effects of adalimumab on workproductivity and sickleave measured by workrelated questionnaires during 52 weeks follow-up.

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