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REstore Working Ability in RheumatoiD Arthritis (REWARD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01405326
Recruitment Status : Unknown
Verified July 2011 by The Rheumatological Center of Helsinki.
Recruitment status was:  Recruiting
First Posted : July 29, 2011
Last Update Posted : July 29, 2011
Information provided by:
The Rheumatological Center of Helsinki

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: adalimumab Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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 Start Date : May 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arm Intervention/treatment
Experimental: Adalimumab
Adalimumab treatment for 6 months
Biological: adalimumab
40mg sc. every two weeks for six months
Other Name: Humira

Placebo Comparator: Pacebo
Corresponding placebo for active treatment group
Biological: adalimumab
40mg sc. every two weeks for six months
Other Name: Humira

Primary Outcome Measures :
  1. Number of lost work days due to RA during the 6-month follow up. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change in health-related quality of life as measured by the EQ-5D index over the 6-month follow up [ Time Frame: baseline and 6 months ]
  2. Change in functionality assessed by the HAQ over the 6-month follow up [ Time Frame: baseline and 6 months ]
  3. Change in disease activity measured with DAS28 with CRP and ESR over the 6-month follow up [ Time Frame: baseline and 6 months ]
  4. Work Productivity and Activity Impairment Questionnaire (WPAI) [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01405326

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Contact: Kari K Eklund, MD +358405832866
Contact: Kari Puolakka, MD +358408354734

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Helsinki University Central Hopsital Recruiting
Helsinki, Finland, 00029
Contact: Ritva Peltomaa, MD    +35894711   
Principal Investigator: Ritva Peltomaa, MD         
Sub-Investigator: Heikki Valleala, MD         
Lappland Central Hospital Recruiting
Rovaniemi, Finland, 96101
Contact: Toini Uutela, MD   
Principal Investigator: Toini Uutela, MD         
Tampere University hospital, Rheumatology Centre Recruiting
Tampere, Finland, 33521
Contact: Heidi Mäkinen, MD   
Principal Investigator: Heidi Mäkinen, MD         
The Turku Universitry Central Hopsital Recruiting
Turku, Finland
Contact: Laura Pirilä, MD   
Principal Investigator: Laura Pirilä, MD         
Sponsors and Collaborators
The Rheumatological Center of Helsinki
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Principal Investigator: Kari K Eklund, MD The Rheumatological Center of Helsinki

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Responsible Party: Kari Eklund MD, Chief of medical affairs, The Rheumatological Center of Helsinki Identifier: NCT01405326     History of Changes
Other Study ID Numbers: RE100002011
First Posted: July 29, 2011    Key Record Dates
Last Update Posted: July 29, 2011
Last Verified: July 2011

Keywords provided by The Rheumatological Center of Helsinki:
rheumatoid arthritis
biological therapy
ability to work
sick leaves

Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents
Antirheumatic Agents