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REstore Working Ability in RheumatoiD Arthritis (REWARD)

28. juli 2011 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

160

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

25 år til 55 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Adalimumab
Adalimumab treatment for 6 months
Biologisk: adalimumab
40mg sc. every two weeks for six months
Andre navne:
  • Humira
Placebo komparator: Pacebo
Corresponding placebo for active treatment group
Biologisk: adalimumab
40mg sc. every two weeks for six months
Andre navne:
  • Humira

Hvad måler undersøgelsen?

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The Rheumatological Center of Helsinki

Samarbejdspartnere

Abbott

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2011

Primær færdiggørelse (Forventet)

1. december 2012

Studieafslutning (Forventet)

1. marts 2013

Datoer for studieregistrering

Først indsendt

30. juni 2011

Først indsendt, der opfyldte QC-kriterier

28. juli 2011

Først opslået (Skøn)

29. juli 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. juli 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. juli 2011

Sidst verificeret

1. juli 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RE100002011

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Rheumatoid arthritis

Kliniske forsøg med adalimumab

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Russia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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