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

ISRCTN	ISRCTN68762628
DOI	https://doi.org/10.1186/ISRCTN68762628
Protocol serial number	N/A
Sponsor	Academic Medical Center
Funder	Academic Medical Center (AMC) (The Netherlands)

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

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
Email	c.a.wijbrandts@amc.uva.nl

Study information

Primary study design	Interventional
Study design	Single-centre open-label prospective, exploratory phase IV study
Secondary study design	Randomised controlled trial
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
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Adalimumab
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	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
Completion date	07/04/2005

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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.