- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01752855
Study in Rheumatoid Arthritis for Subjects Who Completed Preceding Study M13-390 With Adalimumab
A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects Who Completed Preceding Study M13-390 With Adalimumab
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Brussels, Belgio, 1200
- Site Reference ID/Investigator# 92053
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Liege, Belgio, 4000
- Site Reference ID/Investigator# 92054
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Ratingen, Germania, 40882
- Site Reference ID/Investigator# 92073
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Vega Baja, Porto Rico, 00693
- Site Reference ID/Investigator# 92074
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Brno, Repubblica Ceca, 638 00
- Site Reference ID/Investigator# 91954
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Prague 2, Repubblica Ceca, 128 50
- Site Reference ID/Investigator# 91955
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Uherske Hradiste, Repubblica Ceca, 686 01
- Site Reference ID/Investigator# 91953
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Zlin, Repubblica Ceca, 760 01
- Site Reference ID/Investigator# 91956
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Bucharest, Romania, 020475
- Site Reference ID/Investigator# 92093
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Cluj-Napoca, Romania, 400006
- Site Reference ID/Investigator# 92095
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Ploiesti, Romania, 100337
- Site Reference ID/Investigator# 92094
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Banska Bystrica, Slovacchia, 97405
- Site Reference ID/Investigator# 92096
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Senica, Slovacchia, 905 01
- Site Reference ID/Investigator# 92097
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Zilina, Slovacchia, 010 01
- Site Reference ID/Investigator# 92098
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Arizona
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Mesa, Arizona, Stati Uniti, 85202
- Site Reference ID/Investigator# 92113
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California
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Hemet, California, Stati Uniti, 92543
- Site Reference ID/Investigator# 92118
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Kansas
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Wichita, Kansas, Stati Uniti, 67203
- Site Reference ID/Investigator# 92117
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New Jersey
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Clifton, New Jersey, Stati Uniti, 07012
- Site Reference ID/Investigator# 92115
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19152
- Site Reference ID/Investigator# 92116
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South Carolina
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Charleston, South Carolina, Stati Uniti, 29406
- Site Reference ID/Investigator# 92114
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Subject has completed the preceding Study M13-390 for rheumatoid arthritis and has not developed any discontinuation criteria from that study.
If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy) or is of childbearing potential and is practicing an approved method of birth control throughout the study and for 150 days after last dose of study drug. Examples of approved methods of birth control include the following (see local informed consent for more detail):
- Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD);
- Hormonal contraceptives for 90 days prior to study drug administration;
- A vasectomized partner.
- Subjects must be able and willing to self-administer subcutaneous (SC) injections or have a qualified person available to administer SC injections.
- Subject is judged to be in good general health as determined by the Principal Investigator based upon the results of medical history, physical examination, laboratory profile performed at Baseline.
- Subjects must be able and willing to provide written informed consent and to comply with the requirements of this study protocol.
Exclusion Criteria:
- Ongoing infections at Week 0 that have NOT been successfully treated. Subjects with ongoing infections undergoing treatment may be enrolled BUT NOT dosed until the infection has been successfully treated.
- Subject currently uses or plans to use anti-retroviral therapy at any time during the study.
- Subject plans to use any live vaccine during the study.
- Positive pregnancy test at Baseline (Week 0).
- Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Nuova formulazione di adalimumab 40 mg a settimane alterne
Nuova formulazione adalimumab 40 mg a settimane alterne
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New formulation adalimumab 40 mg every other week
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Mean Change From Baseline in Disease Activity Score 28 (DAS28) at Weeks 36 and 48
Lasso di tempo: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
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The Disease Activity Score (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.
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Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
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Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 36 and 48
Lasso di tempo: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
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American College of Rheumatology 20% (ACR20) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:
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Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
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Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 36 and 48
Lasso di tempo: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
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American College of Rheumatology 50% (ACR50) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:
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Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
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Mean Change From Baseline in Health Assessment Questionnaire (HAQ-DI) at Weeks 36 and 48
Lasso di tempo: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
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The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis.
It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities.
Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3).
Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability.
The minimal clinically important difference (MCID) defined for the HAQ-DI is 0.22.
HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5.
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Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Percentage of Participants Positive for Anti-adalimumab Antibody
Lasso di tempo: Week 24 through Week 48
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Percentage of participants with anti-adalimumab antibody
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Week 24 through Week 48
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Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Andy Payne, PhD, AbbVie
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- M13-692
- 2012-003881-42 (Numero EudraCT)
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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