The effect of Six months Adalimumab Treatment on Sick Leaves and retirement in Patients with rheumatoid Arthritis who are at risk of losing their ability to work”
- Conditions
- Rheumatoid arthritisMedDRA version: 12.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis
- Registration Number
- EUCTR2009-017325-19-FI
- Lead Sponsor
- Helsingin reumakeskus
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
1)A diagnosis of RA according to the 1987 revised American College of Rheumatology (ACR) criteria
2)RA duration of < 2 years
3)Age 25-55 years
4)Active RA with at least 3 active joints (tender and/or swollen joints)
5)Stable DMARD combination treatment for more than 3 months
6)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
7)At least other of the following
HAQ-index 0.5 or more
Patient or physician evaluation of RA activity >25 mm (VAS 10 cm)
8)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
9)Patient feels that he/she will likely have to be off-work during the following 6 months due to his/her RA
10)Patient must be willing and able to provide written informed consent for the trial
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
1)A subject must not have a history of biological drug use for RA
2)A subject must not have evidence of active or latent tuberculosis,
3)A subject must not have any history of lymphoproliferative disease or malignancy within the previous 5 years
4)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
5)A subject must not have no inflammatory rheumatic disease other than RA
6)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
7)A female subject must not be pregnant or breast-feeding or planning pregnancy during the following year
8)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
9)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.
10) 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method