Clinical trial NCT01405326: REstore Working Ability in RheumatoiD Arthritis
Official title: The Effect of Six Months Adalimumab Treatment on Sick Leaves and Retirement in Patients With Rheumatoid Arthritis Who Are at a Risk of Losing Their Ability to Work
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis
biological therapy
adalimumab
ability to work
sick leaves
Lead sponsor: The Rheumatological Center of Helsinki
Sponsor class: NETWORK
Collaborators: name: Abbott
First posted: 2011-07-29
Enrollment: 160
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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 compared to placebo. In addition, the cost-effectiveness and cost-utility of the intervention compared to the conventional treatment is evaluated, and the patients who benefit most are characterized.

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 leaves represent a significant part of the socioeconomic burden of RA. The study is a randomized, controlled double blind multi-center study. 160 patients of 25 to 55 years of age with recent-onset (≤2 years from diagnosis) RA who have been treated with a combination of conventional antirheumatic drugs but have an inadequate response to treatment and are at the risk of losing their ability to work, are enrolled. The patients should be biologic-naïve. Their RA should be active, but not so active that the conventional criteria for biologic therapy would be fulfilled. The subjects are randomized at 1:1 ratio to receive either adalimumab (40 mg every two weeks) or placebo for 6 months added on their concurrent antirheumatic therapy. The RA-related sickness absence and clinical response will be evaluated.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of RA according to the 1987 revised American College of Rheumatology (ACR) criteria
2. Time from diagnosis of RA \< 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 0-10 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
11. Each female subject must agree to use a medically accepted method of contraception while receiving study medication

Exclusion Criteria:

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 any 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 study
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
11. A patient must not be currently on reimbursed rehabilitation period, or such period must not be scheduled for the next six months

Primary outcomes:
measure: Number of lost work days due to RA during the 6-month follow up.
timeFrame: 6 months
Secondary outcomes:
measure: Change in health-related quality of life as measured by the EQ-5D index over the 6-month follow up
timeFrame: baseline and 6 months
measure: Change in functionality assessed by the HAQ over the 6-month follow up
timeFrame: baseline and 6 months
measure: Change in disease activity measured with DAS28 with CRP and ESR over the 6-month follow up
timeFrame: baseline and 6 months
measure: Work Productivity and Activity Impairment Questionnaire (WPAI)
timeFrame: 6 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hopsital
city: Rovaniemi
country: Finland
facility: Lappland Central Hospital
city: Tampere
country: Finland
facility: Tampere University hospital, Rheumatology Centre
city: Turku
country: Finland
facility: The Turku Universitry Central Hopsital
Study officials:
affiliation: The Rheumatological Center of Helsinki
name: Kari K Eklund, MD
role: PRINCIPAL_INVESTIGATOR
References: