Prospective study on the effects of adalimumab treatment in patients with rheumatoid arthritis
| ISRCTN | ISRCTN68762628 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68762628 |
| Secondary identifying numbers | N/A |
- Submission date
- 22/01/2007
- Registration date
- 22/01/2007
- Last edited
- 06/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr C A Wijbrandts
Scientific
Scientific
Academic Medical Center (AMC)
Department of Medicine
Division of Clinical Immunology and Rheumatology, F4-218
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 566 2171 |
|---|---|
| c.a.wijbrandts@amc.uva.nl |
Study information
| Study design | Single-centre open-label prospective, exploratory phase IV study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Prospective study on the effects of adalimumab treatment in patients with rheumatoid arthritis |
| Study acronym | adalimumab |
| Study objectives | To evaluate the response to adalimumab treatment in Tumour Necrotising Factor (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. |
| Ethics approval(s) | Approval received from the Medical ethical committee of the Academic Medical Center/University of Amsterdam on the 12/02/2004 (ref: MEC04/007) |
| Health condition(s) or problem(s) studied | Rheumatoid arthritis |
| Intervention | Adalimumab 40 mg subcutaneously once every two weeks. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Adalimumab |
| Primary outcome measure | 1. Clinical efficacy according to the EUropean League Against Rheumatism (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 measures | 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 bone mineral density as measured by Dual Energy X-ray Absortiometry (DEXA) scanning 4. The effects of adalimumab on lipid metabolism as measured by fasting serum lipid profiles in time 5. The effects of adalimumab on work productivity and sick leave measured by work-related questionnaires during 52 weeks follow-up |
| Overall study start date | 07/04/2004 |
| Completion date | 07/04/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 50 |
| Key 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 provided that the dosage has been stable for at least two months prior to entry |
| Key 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 |
| Date of first enrolment | 07/04/2004 |
| Date of final enrolment | 07/04/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Academic Medical Center
Hospital/treatment centre
Hospital/treatment centre
Division of Clinical Immunology and Rheumatology
PO Box 22660
Amsterdam
1100 DD
Netherlands
| Website | http://www.amc.uva.nl/ |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Hospital/treatment centre
Academic Medical Center (AMC) (The Netherlands)
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Academic Medical Center, AMC
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2008 | 06/01/2021 | Yes | No |
Editorial Notes
06/01/2021: Publication reference added.
