REstore Working Ability in RheumatoiD Arthritis - Full Text View

Purpose

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	Intervention	Phase
Rheumatoid Arthritis	Biological: adalimumab	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Adalimumab

U.S. FDA Resources

Further study details as provided by The Rheumatological Center of Helsinki:

Primary Outcome Measures:

Number of lost work days due to RA during the 6-month follow up. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Change in functionality assessed by the HAQ over the 6-month follow up [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
Change in disease activity measured with DAS28 with CRP and ESR over the 6-month follow up [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
Work Productivity and Activity Impairment Questionnaire (WPAI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	160
Study Start Date:	May 2011
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Ages Eligible for Study:	25 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01405326

Contacts

Contact: Kari K Eklund, MD	+358405832866	kari.eklund@welho.com
Contact: Kari Puolakka, MD	+358408354734	kari.puolakka@eksote.fi

Locations

Finland
Helsinki University Central Hopsital	Recruiting
Helsinki, Finland, 00029
Contact: Ritva Peltomaa, MD +35894711 ritva.peltomaa@hus.fi
Principal Investigator: Ritva Peltomaa, MD
Sub-Investigator: Heikki Valleala, MD
Lappland Central Hospital	Recruiting
Rovaniemi, Finland, 96101
Contact: Toini Uutela, MD toini.uutela@lshp.fi
Principal Investigator: Toini Uutela, MD
Tampere University hospital, Rheumatology Centre	Recruiting
Tampere, Finland, 33521
Contact: Heidi Mäkinen, MD heidi.m.makinen@pshp.fi
Principal Investigator: Heidi Mäkinen, MD
The Turku Universitry Central Hopsital	Recruiting
Turku, Finland
Contact: Laura Pirilä, MD laura.pirila@tyks.fi
Principal Investigator: Laura Pirilä, MD

Sponsors and Collaborators

The Rheumatological Center of Helsinki

Abbott

Investigators

Principal Investigator:

Kari K Eklund, MD

The Rheumatological Center of Helsinki

More Information

No publications provided

Responsible Party:	Kari Eklund MD, Chief of medical affairs, The Rheumatological Center of Helsinki
ClinicalTrials.gov Identifier:	NCT01405326 History of Changes
Other Study ID Numbers:	RE100002011
Study First Received:	June 30, 2011
Last Updated:	July 28, 2011
Health Authority:	Finland: Finnish Medicines Agency

Keywords provided by The Rheumatological Center of Helsinki:

rheumatoid arthritis
biological therapy
adalimumab
ability to work
sick leaves

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases

Immune System Diseases
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 23, 2013

REstore Working Ability in RheumatoiD Arthritis (REWARD)