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REstore Working Ability in RheumatoiD Arthritis (REWARD)

28. juli 2011 oppdatert 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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Forventet)

160

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Finland
      • Helsinki, Finland, 00029
        • Rekruttering
        • Helsinki University Central Hopsital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Ritva Peltomaa, MD
        • Underetterforsker:
          • Heikki Valleala, MD
      • Rovaniemi, Finland, 96101
        • Rekruttering
        • Lappland Central Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Toini Uutela, MD
      • Tampere, Finland, 33521
        • Rekruttering
        • Tampere University hospital, Rheumatology Centre
        • Ta kontakt med:
        • Hovedetterforsker:
          • Heidi Mäkinen, MD
      • Turku, Finland
        • Rekruttering
        • The Turku Universitry Central Hopsital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Laura Pirilä, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

25 år til 55 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Adalimumab
Adalimumab treatment for 6 months
Biologisk: adalimumab
40mg sc. every two weeks for six months
Andre navn:
  • Humira
Placebo komparator: Pacebo
Corresponding placebo for active treatment group
Biologisk: adalimumab
40mg sc. every two weeks for six months
Andre navn:
  • Humira

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

The Rheumatological Center of Helsinki

Samarbeidspartnere

Abbott

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mai 2011

Primær fullføring (Forventet)

1. desember 2012

Studiet fullført (Forventet)

1. mars 2013

Datoer for studieregistrering

Først innsendt

30. juni 2011

Først innsendt som oppfylte QC-kriteriene

28. juli 2011

Først lagt ut (Anslag)

29. juli 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

29. juli 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. juli 2011

Sist bekreftet

1. juli 2011

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RE100002011

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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