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REstore Working Ability in RheumatoiD Arthritis (REWARD)

28 juli 2011 uppdaterad av: 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.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Förväntat)

160

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Finland
      • Helsinki, Finland, 00029
        • Rekrytering
        • Helsinki University Central Hopsital
        • Kontakt:
        • Huvudutredare:
          • Ritva Peltomaa, MD
        • Underutredare:
          • Heikki Valleala, MD
      • Rovaniemi, Finland, 96101
        • Rekrytering
        • Lappland Central Hospital
        • Kontakt:
        • Huvudutredare:
          • Toini Uutela, MD
      • Tampere, Finland, 33521
        • Rekrytering
        • Tampere University hospital, Rheumatology Centre
        • Kontakt:
        • Huvudutredare:
          • Heidi Mäkinen, MD
      • Turku, Finland
        • Rekrytering
        • The Turku Universitry Central Hopsital
        • Kontakt:
        • Huvudutredare:
          • Laura Pirilä, MD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

25 år till 55 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Adalimumab
Adalimumab treatment for 6 months
Biologisk: adalimumab
40mg sc. every two weeks for six months
Andra namn:
  • Humira
Placebo-jämförare: Pacebo
Corresponding placebo for active treatment group
Biologisk: adalimumab
40mg sc. every two weeks for six months
Andra namn:
  • Humira

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Number of lost work days due to RA during the 6-month follow up.
Tidsram: 6 months
6 months

Sekundära resultatmått

Resultatmått
Tidsram
Change in health-related quality of life as measured by the EQ-5D index over the 6-month follow up
Tidsram: baseline and 6 months
baseline and 6 months
Change in functionality assessed by the HAQ over the 6-month follow up
Tidsram: 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
Tidsram: baseline and 6 months
baseline and 6 months
Work Productivity and Activity Impairment Questionnaire (WPAI)
Tidsram: 6 months
6 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

The Rheumatological Center of Helsinki

Samarbetspartners

Abbott

Utredare

  • Huvudutredare: Kari K Eklund, MD, The Rheumatological Center of Helsinki

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 maj 2011

Primärt slutförande (Förväntat)

1 december 2012

Avslutad studie (Förväntat)

1 mars 2013

Studieregistreringsdatum

Först inskickad

30 juni 2011

Först inskickad som uppfyllde QC-kriterierna

28 juli 2011

Första postat (Uppskatta)

29 juli 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

29 juli 2011

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 juli 2011

Senast verifierad

1 juli 2011

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • RE100002011

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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