- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01405326
REstore Working Ability in RheumatoiD Arthritis (REWARD)
July 28, 2011 updated by: The Rheumatological Center of Helsinki
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
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
160
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kari K Eklund, MD
- Phone Number: +358405832866
- Email: kari.eklund@welho.com
Study Contact Backup
- Name: Kari Puolakka, MD
- Phone Number: +358408354734
- Email: kari.puolakka@eksote.fi
Study Locations
-
-
-
Helsinki, Finland, 00029
- Recruiting
- Helsinki University Central Hopsital
-
Contact:
- Ritva Peltomaa, MD
- Phone Number: +35894711
- Email: ritva.peltomaa@hus.fi
-
Principal Investigator:
- Ritva Peltomaa, MD
-
Sub-Investigator:
- Heikki Valleala, MD
-
Rovaniemi, Finland, 96101
- Recruiting
- Lappland Central Hospital
-
Contact:
- Toini Uutela, MD
- Email: toini.uutela@lshp.fi
-
Principal Investigator:
- Toini Uutela, MD
-
Tampere, Finland, 33521
- Recruiting
- Tampere University hospital, Rheumatology Centre
-
Contact:
- Heidi Mäkinen, MD
- Email: heidi.m.makinen@pshp.fi
-
Principal Investigator:
- Heidi Mäkinen, MD
-
Turku, Finland
- Recruiting
- The Turku Universitry Central Hopsital
-
Contact:
- Laura Pirilä, MD
- Email: laura.pirila@tyks.fi
-
Principal Investigator:
- Laura Pirilä, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Adalimumab
Adalimumab treatment for 6 months
|
40mg sc.
every two weeks for six months
Other Names:
|
Placebo Comparator: Pacebo
Corresponding placebo for active treatment group
|
40mg sc.
every two weeks for six months
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of lost work days due to RA during the 6-month follow up.
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
baseline and 6 months
|
Change in functionality assessed by the HAQ over the 6-month follow up
Time Frame: baseline and 6 months
|
baseline and 6 months
|
Change in disease activity measured with DAS28 with CRP and ESR over the 6-month follow up
Time Frame: baseline and 6 months
|
baseline and 6 months
|
Work Productivity and Activity Impairment Questionnaire (WPAI)
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Kari K Eklund, MD, The Rheumatological Center of Helsinki
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Anticipated)
December 1, 2012
Study Completion (Anticipated)
March 1, 2013
Study Registration Dates
First Submitted
June 30, 2011
First Submitted That Met QC Criteria
July 28, 2011
First Posted (Estimate)
July 29, 2011
Study Record Updates
Last Update Posted (Estimate)
July 29, 2011
Last Update Submitted That Met QC Criteria
July 28, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RE100002011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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