| - candidate number | 2383 |
| - NTR Number | NTR857 |
| - ISRCTN | ISRCTN68762628 |
| - Date ISRCTN created | 22-jan-2007 |
| - date ISRCTN requested | 12-jan-2007 |
| - Date Registered NTR | 29-dec-2006 |
| - Secondary IDs | N/A |
| - Public Title | Prospective study on the effects of adalimumab treatment in patients with rheumatoid arthritis. |
| - Scientific Title | Prospective study on the effects of adalimumab treatment in patients with rheumatoid arthritis . |
| - ACRONYM | adalimumab |
| - hypothesis | To evaluate the response to adalimumab treatment in TNF-alpha blockade naïve patients and patients who failed prior other anti-TNF-alpha treatment and to understand the mechanisms underlying the clinical response to TNF-alpha blockade. |
| - Healt Condition(s) or Problem(s) studied | Rheumatoid arthritis |
| - 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. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | no |
| - group | [default] |
| - Type | [default] |
| - Studytype | intervention |
| - planned startdate | 7-apr-2004 |
| - planned closingdate | |
| - Target number of participants | 50 |
| - Interventions | Adalimumab 40mg subcutaneously 1x/2 weeks. |
| - Primary outcome | 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 outcome | 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. |
| - Timepoints | |
| - Trial web site | N/A |
| - status | inclusion stopped: follow-up |
| - CONTACT FOR PUBLIC QUERIES | C.A. Wijbrandts |
| - CONTACT for SCIENTIFIC QUERIES | Prof. Dr. P.P. Tak |
| - Sponsor/Initiator | Academic Medical Center (AMC), Division of Clinical Immunology and Rheumatology |
| - Funding (Source(s) of Monetary or Material Support) | Academic Medical Center (AMC), Division of Clinical Immunology and Rheumatology |
| - Publications | N/A |
| - Brief summary | Monocenter open label prospective, exploratory phase IV study into the effects of adalimumab treatment in patients with rheumatoid arthritis that are starting treatment with a TNF blocker as part of routine patient care. The patients have never before received TNF blockade or failed prior TNF blocking therapy. A total of 50 patiënts with rheumatoid arthritis will be included and treated with adalimumab 40 mg/2wks s.c. and followed up until week 52. Clinical efficacy parameters will be measured every 12 weeks from baseline. Factors influencing clinical efficacy of adalimumab will be studied. Furthermore the effect of adalimumab on lipidmetabolism, bonemineraldensity and workproductivity will be determined. |
| - Main changes (audit trail) | |
| - RECORD | 29-dec-2006 - 16-jan-2011 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl