Status:
UNKNOWN
REstore Working Ability in RheumatoiD Arthritis
Lead Sponsor:
The Rheumatological Center of Helsinki
Collaborating Sponsors:
Abbott
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
25-55 years
Phase:
PHASE4
Brief Summary
The purpose of the study is to assess whether a 6-month treatment with adalimumab added on the treatment with conventional antirheumatic drugs (DMARD) will decrease the number of days on sick leave co...
Detailed Description
In spite of the improved medical treatment, rheumatoid arthritis (RA) is still causing both significant morbidity and marked loss of work productivity. Short periods of work inability, i.e., sick leav...
Eligibility Criteria
Inclusion
- Diagnosis of RA according to the 1987 revised American College of Rheumatology (ACR) criteria
- Time from diagnosis of RA \< 2 years
- Age 25-55 years
- Active RA with at least 3 active joints (tender and/or swollen joints)
- Stable DMARD combination treatment for more than 3 months
- At least one of the following
- Rheumatoid factor positive
- One or more erosions in x-rays of the hands and feet
- Anti-citrulline antibodies positive
- At least other of the following
- HAQ-index 0.5 or more
- Patient or physician evaluation of RA activity \>25 mm (VAS 0-10 cm)
- Patient has been steadily in work-life for at least one year and is currently working or on sick- leave but not applying for pension
- Patient feels that he/she will likely have to be off-work during the following 6 months due to his/her RA
- Patient must be willing and able to provide written informed consent for the trial
- Each female subject must agree to use a medically accepted method of contraception while receiving study medication
Exclusion
- A subject must not have a history of biological drug use for RA
- A subject must not have evidence of active or latent tuberculosis,
- A subject must not have any history of lymphoproliferative disease or malignancy within the previous 5 years
- A subject must not have any other condition, that according to the investigator's judgment makes him or her non-eligible for anti-TNF use
- A subject must not have any inflammatory rheumatic disease other than RA
- A subject must not have received any other investigational agents within 30 days prior to baseline visit, and must not receive them during the current trial
- A female subject must not be pregnant or breast-feeding or planning pregnancy during the study
- A subject must not have had a major surgery within one month prior to study entry and must not have a scheduled operation during the 6-month follow up
- A subject must not have any clinically significant condition or situation, other than the condition being studied, that in the opinion of the investigator would interfere with the optimal participation in the trial.
- A subject must not fulfill the criteria for reimbursement for biologics for RA and he/she would not normally be prescribed a biological drug according to physicians discretion and national treatment guidelines
- A patient must not be currently on reimbursed rehabilitation period, or such period must not be scheduled for the next six months
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2013
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT01405326
Start Date
May 1 2011
End Date
March 1 2013
Last Update
July 29 2011
Active Locations (4)
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1
Helsinki University Central Hopsital
Helsinki, Finland, 00029
2
Lappland Central Hospital
Rovaniemi, Finland, 96101
3
Tampere University hospital, Rheumatology Centre
Tampere, Finland, 33521
4
The Turku Universitry Central Hopsital
Turku, Finland