REstore Working Ability in RheumatoiD Arthritis

NCT01405326 | Unknown Phase 4

• 1 other identifier: RE100002011
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 4

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.

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis; biological therapy; adalimumab; ability to work; sick leaves

Outcome Measures

Primary Outcomes (1)

• Number of lost work days due to RA during the 6-month follow up.

  6 months

Secondary Outcomes (4)

• Change in health-related quality of life as measured by the EQ-5D index over the 6-month follow up

  baseline and 6 months

• Change in functionality assessed by the HAQ over the 6-month follow up

  baseline and 6 months

• Change in disease activity measured with DAS28 with CRP and ESR over the 6-month follow up

  baseline and 6 months

• Work Productivity and Activity Impairment Questionnaire (WPAI)

  6 months

Study Arms (2)

Adalimumab

EXPERIMENTAL

Adalimumab treatment for 6 months

Biological: adalimumab

Pacebo

PLACEBO COMPARATOR

Corresponding placebo for active treatment group

Biological: adalimumab

Interventions

adalimumab BIOLOGICAL

40mg sc. every two weeks for six months

Also known as: Humira

Adalimumab; Pacebo

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Rheumatological Center of Helsinki: lead
• Abbott: collaborator

Study Sites (4)

Helsinki University Central Hopsital

Helsinki, 00029, Finland

RECRUITING

Lappland Central Hospital

Rovaniemi, 96101, Finland

RECRUITING

Tampere University hospital, Rheumatology Centre

Tampere, 33521, Finland

RECRUITING

The Turku Universitry Central Hopsital

Turku, Finland

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Kari K Eklund, MD

  The Rheumatological Center of Helsinki

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kari K Eklund, MD

CONTACT

+358405832866; kari.eklund@welho.com

Kari Puolakka, MD

CONTACT

+358408354734; kari.puolakka@eksote.fi

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: June 30, 2011
• First Posted: July 29, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: July 29, 2011

Record last verified: 2011-07

Locations

FI (4)