Contact information
Type
Scientific
Primary contact
Dr C A Wijbrandts
ORCID ID
Contact details
Academic Medical Center (AMC)
Department of Medicine
Division of Clinical Immunology and Rheumatology
F4-218
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 2171
c.a.wijbrandts@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
adalimumab
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
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Rheumatoid arthritis
Intervention
Adalimumab 40 mg subcutaneously once every two weeks.
Intervention type
Drug
Phase
Phase IV
Drug names
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 trial start date
07/04/2004
Overall trial end date
07/04/2005
Reason abandoned (if study stopped)
Eligibility
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
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
50
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
07/04/2004
Recruitment end date
07/04/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands
Sponsor information
Organisation
Academic Medical Center (AMC) (The Netherlands)
Sponsor details
Division of Clinical Immunology and Rheumatology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
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)
Location
Netherlands
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