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A 3-year Study Following up Patients With Moderate to Severe Rheumatoid Arthritis Treated With Humira in Greece

24. september 2013 oppdatert av: AbbVie (prior sponsor, Abbott)

A 3-year Post-marketing Observational Study Following up Patients With Moderate to Severe RA Treated With Humira in Greece

The objectives of the study are to observe and assess the long-term use, safety and efficacy of Humira (adalimumab), as prescribed by the rheumatologist in a normal clinical setting and in accordance with the terms of the European marketing authorization and to observe compliance of patients with the prescribed treatment.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

This is a multi-center, uncontrolled observational study of patients who at the time of entry had moderate to severe rheumatoid arthritis (RΑ) and who were subsequently prescribed Humira (adalimumab) following normal clinical practice, with or without other anti-rheumatic treatments, prior to enrollment in this study.

Once the physician has determined that the patient meets the inclusion criteria, and the patient has agreed to be included in the observational study by signing the informed consent, the patient's Day 1 demographic data, and disease status will be reported in the Day 1 Data Report Forms. The physician will then follow-up with the patient via regular office visits at intervals as determined by routine clinical practice. Patient's safety and efficacy data, if they are part of clinical routine, will be recorded in the Data Report Forms at Day 1, and regular visits which are closest to Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36.

Studietype

Observasjonsmessig

Registrering (Faktiske)

566

Kontakter og plasseringer

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

Studiesteder

  • Hellas
      • A. Glyfada, Hellas
        • Site Reference ID/Investigator# 30116
      • Ag. Dimitrios, Athens, Hellas, 17121
        • Site Reference ID/Investigator# 47544
      • Ag. Paraskevi, Athens, Hellas, 15343
        • Site Reference ID/Investigator# 47542
      • Agioi Anargyroi, Hellas, 13122
        • Site Reference ID/Investigator# 29992
      • Agioi Anargyroi, Hellas
        • Site Reference ID/Investigator# 29954
      • Alexandroupoli, Hellas, 68100
        • Site Reference ID/Investigator# 29915
      • Arta, Hellas, 47100
        • Site Reference ID/Investigator# 30118
      • Athens, Hellas, 10444
        • Site Reference ID/Investigator# 29989
      • Athens, Hellas, 115 21
        • Site Reference ID/Investigator# 29914
      • Athens, Hellas, 115 25
        • Site Reference ID/Investigator# 29950
      • Athens, Hellas, 115 25
        • Site Reference ID/Investigator# 5284
      • Athens, Hellas, 115 27
        • Site Reference ID/Investigator# 29944
      • Athens, Hellas, 115 27
        • Site Reference ID/Investigator# 30474
      • Athens, Hellas, 11521
        • Site Reference ID/Investigator# 29953
      • Athens, Hellas, 11521
        • Site Reference ID/Investigator# 30085
      • Athens, Hellas, 11521
        • Site Reference ID/Investigator# 30472
      • Athens, Hellas, 11527
        • Site Reference ID/Investigator# 30479
      • Athens, Hellas, 11527
        • Site Reference ID/Investigator# 30480
      • Athens, Hellas, 11528
        • Site Reference ID/Investigator# 29899
      • Athens, Hellas, 11635
        • Site Reference ID/Investigator# 30178
      • Athens, Hellas, 12462
        • Site Reference ID/Investigator# 30785
      • Athens, Hellas, 12462
        • Site Reference ID/Investigator# 30788
      • Chalkida, Hellas, 34100
        • Site Reference ID/Investigator# 30198
      • Crete, Hellas, 71201
        • Site Reference ID/Investigator# 30008
      • Crete, Hellas, 74100
        • Site Reference ID/Investigator# 30210
      • Crete, Hellas
        • Site Reference ID/Investigator# 29828
      • Drama, Hellas, 66100
        • Site Reference ID/Investigator# 30105
      • Elefsina, Hellas, 19200
        • Site Reference ID/Investigator# 29820
      • Ermoupolis Syros, Hellas
        • Site Reference ID/Investigator# 30146
      • Heraklion Crete, Hellas, 70013
        • Site Reference ID/Investigator# 30767
      • Holargos, Hellas, 15562
        • Site Reference ID/Investigator# 30789
      • Ioannina, Hellas, 45500
        • Site Reference ID/Investigator# 30482
      • Karditsa, Hellas, 43100
        • Site Reference ID/Investigator# 47322
      • Katerini, Hellas
        • Site Reference ID/Investigator# 29850
      • Kavala, Hellas, 65302
        • Site Reference ID/Investigator# 30189
      • Kifisia, Hellas, 14500
        • Site Reference ID/Investigator# 30476
      • Kozani, Hellas, 50100
        • Site Reference ID/Investigator# 30004
      • Lamia, Hellas, 35100
        • Site Reference ID/Investigator# 29993
      • Larisa, Hellas, 41223
        • Site Reference ID/Investigator# 29988
      • Larissa, Hellas, 411 10
        • Site Reference ID/Investigator# 30770
      • Nikea, Hellas, 18454
        • Site Reference ID/Investigator# 29922
      • Patras, Hellas, 26221
        • Site Reference ID/Investigator# 29972
      • Patras, Hellas, 26335
        • Site Reference ID/Investigator# 29916
      • Peristeri, Hellas, 12134
        • Site Reference ID/Investigator# 29827
      • Pyrgos, Hellas
        • Site Reference ID/Investigator# 29936
      • Rion, Patras, Hellas, 265 00
        • Site Reference ID/Investigator# 30200
      • Thessaloniki, Hellas, 54622
        • Site Reference ID/Investigator# 29900
      • Thessaloniki, Hellas, 54622
        • Site Reference ID/Investigator# 30192
      • Thessaloniki, Hellas, 54623
        • Site Reference ID/Investigator# 30165
      • Thessaloniki, Hellas, 54636
        • Site Reference ID/Investigator# 30765
      • Thessaloniki, Hellas, 54639
        • Site Reference ID/Investigator# 29845
      • Thessaloniki, Hellas, 54642
        • Site Reference ID/Investigator# 30791
      • Thessaloniki, Hellas, 54642
        • Site Reference ID/Investigator# 30792
      • Thessaloniki, Hellas, 54643
        • Site Reference ID/Investigator# 47543
      • Thessaloniki, Hellas, 55134
        • Site Reference ID/Investigator# 29924
      • Thessaloniki, Hellas, 564 29
        • Site Reference ID/Investigator# 30477
      • Thessaloniki, Hellas, 570 10
        • Site Reference ID/Investigator# 29947
      • Trikala, Hellas, 42100
        • Site Reference ID/Investigator# 30115
      • Veria, Hellas
        • Site Reference ID/Investigator# 30084
      • Xanthi, Hellas, 67100
        • Site Reference ID/Investigator# 29968

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Patients with Rheumatoid Arthritis on Humira (adalimimab) treatment

Beskrivelse

Inclusion Criteria:

  • Patients with moderate or severe active rheumatoid arthritis, who have been prescribed and are receiving Humira (adalimumab) under normal clinical practice for at least one month prior to inclusion and according to the approved Summary of Product Characteristics (SPC) in the European Union.
  • Patients must be willing to consent to data being collected and provided to Abbott Laboratories.

Exclusion Criteria:

  • Contraindications according to the SPC.
  • Patients should not participate in another observational Abbott study.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Humira
Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants With Adverse Events
Tidsramme: 3 years

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): Results in death, is life-threatening, results in hospitalization or the prolongation of hospitalization, is a congenital anomaly or a persistent or significant disability/incapacity, is an event that results in a condition that substantially interferes with the activities of daily living of the participant, is an important medical event requiring medical or surgical intervention to prevent a serious outcome, spontaneous abortion or miscarriage experienced by the participant, or an elective abortion performed on the participant.
3 years
Disease Activity Score (DAS) 28 Over Time
Tidsramme: Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36
The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36
European League Against Rheumatism (EULAR) Response
Tidsramme: Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36

A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity.

A Good EULAR Response is defined as an improvement (decrease) in the DAS28 of > 1.2 compared with Baseline and attainment of a DAS28 score of ≤ 3.2.

A Moderate EULAR Response is defined as either:

  • an improvement (decrease) in the DAS28 of > 0.6 and ≤ 1.2 from Baseline and attainment of a DAS28 score of ≤ 5.1, or
  • an improvement (decrease) in the DAS28 of > 1.2 from Baseline and attainment of a DAS28 score of > 3.2.

No Response is defined as either:

  • an improvement (decrease) in the DAS28 of ≤ to 0.6, or
  • an improvement (decrease) in the DAS28 of > 0.6 and ≤ 1.2 and attainment of a DAS28 of > 5.1.
Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36
Number of Participants With an American College of Rheumatology (ACR) 20 Response
Tidsramme: Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36

American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:

  • ≥ 20% improvement in tender joint count;
  • ≥ 20% improvement in swollen joint count; and

  • ≥ 20% improvement in at least 3 of the 5 following parameters:

    • Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
    • Patient's global assessment of disease activity (measured on a 100 mm VAS);
    • Physician's global assessment of disease activity (measured on a 100 mm VAS);
    • Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
    • Acute phase reactant value (C-reactive protein [CRP]).
Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36
Number of Participants With an American College of Rheumatology (ACR) 50 Response
Tidsramme: Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36

American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:

  • ≥ 50% improvement in tender joint count;
  • ≥ 50% improvement in swollen joint count; and

  • ≥ 50% improvement in at least 3 of the 5 following parameters:

    • Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
    • Patient's global assessment of disease activity (measured on a 100 mm VAS);
    • Physician's global assessment of disease activity (measured on a 100 mm VAS);
    • Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
    • Acute phase reactant value (C-reactive protein [CRP]).
Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36
Number of Participants With an American College of Rheumatology (ACR) 70 Response
Tidsramme: Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36

American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:

  • ≥ 70% improvement in tender joint count;
  • ≥ 70% improvement in swollen joint count; and

  • ≥ 70% improvement in at least 3 of the 5 following parameters:

    • Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
    • Patient's global assessment of disease activity (measured on a 100 mm VAS);
    • Physician's global assessment of disease activity (measured on a 100 mm VAS);
    • Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
    • Acute phase reactant value (C-reactive protein [CRP]).
Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants Who Missed at Least One Dose of Humira
Tidsramme: Months 3, 6, 9, 12, 18, 24, 30, and 36
Compliance to study treatment was measured by the percentage of participants who missed at least one dose of Humira during each time interval between study visits.
Months 3, 6, 9, 12, 18, 24, 30, and 36

Samarbeidspartnere og etterforskere

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

Sponsor

AbbVie (prior sponsor, Abbott)

Etterforskere

  • Studiestol: Thanasis Floros, MD, AbbVie Pharmaceuticals S.A.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

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 2006

Primær fullføring (Faktiske)

1. juli 2012

Studiet fullført (Faktiske)

1. juli 2012

Datoer for studieregistrering

Først innsendt

26. februar 2010

Først innsendt som oppfylte QC-kriteriene

11. mars 2010

Først lagt ut (Anslag)

12. mars 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

26. september 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. september 2013

Sist bekreftet

1. september 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PMOS GREC 2004 06

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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