Condition category
Musculoskeletal Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr C A Wijbrandts


Contact details

Academic Medical Center (AMC)
Department of Medicine
Division of Clinical Immunology and Rheumatology
P.O. Box 22660
1100 DD
+31 (0)20 566 2171

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title



Study hypothesis

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

Approval received from the Medical ethical committee of the Academic Medical Center/University of Amsterdam on the 12th February 2004 (ref: MEC04/007).

Study design

Single-centre open label prospective, exploratory phase IV study

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet


Rheumatoid arthritis


Adalimumab 40 mg subcutaneously once every two weeks.

Intervention type



Phase IV

Drug names


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 trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant 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 rovided that the dosage has been stable for at least two months prior to entry

Participant type


Age group

Not Specified


Not Specified

Target number of participants


Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Academic Medical Center (AMC)
1100 DD

Sponsor information


Academic Medical Center (AMC) (The Netherlands)

Sponsor details

Division of Clinical Immunology and Rheumatology
P.O. Box 22660
1100 DD

Sponsor type

Hospital/treatment centre



Funder type

Hospital/treatment centre

Funder name

Academic Medical Center (AMC) (The Netherlands)

Alternative name(s)

Academic Medical Center, AMC

Funding Body Type

private sector organisation

Funding Body Subtype

Universities (academic only)



Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes