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

24 settembre 2013 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

566

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Patients with Rheumatoid Arthritis on Humira (adalimimab) treatment

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Adverse Events
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants Who Missed at Least One Dose of Humira
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

AbbVie (prior sponsor, Abbott)

Investigatori

  • Cattedra di studio: Thanasis Floros, MD, AbbVie Pharmaceuticals S.A.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 maggio 2006

Completamento primario (Effettivo)

1 luglio 2012

Completamento dello studio (Effettivo)

1 luglio 2012

Date di iscrizione allo studio

Primo inviato

26 febbraio 2010

Primo inviato che soddisfa i criteri di controllo qualità

11 marzo 2010

Primo Inserito (Stima)

12 marzo 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

26 settembre 2013

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 settembre 2013

Ultimo verificato

1 settembre 2013

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PMOS GREC 2004 06

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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