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SNCTP000002220 | NCT02873936 | BASEC2017-00215

Filgotinib versus Placebo bei Erwachsenen mit aktiver rheumatoider Arthritis (RA), die ein unzureichendes Ansprechen auf eine Behandlung mit biologischen krankheitsmodifizierenden Antirheumatika (disease-modifying anti-rheumatic drug(s), DMARDs) gezeigt haben

Base di dati: BASEC (Importata da 29.03.2024), WHO (Importata da 29.03.2024)
Cambiato: 23 dic 2023, 16:52
Categoria di malattie: Malattie muscolo-scheletriche (non cancro)

Descrizione riassuntiva della sperimentazione (Fonte di dati: BASEC)

Zweck dieser Studie ist es, festzustellen, ob Filgotinib für die Behandlung von rheumatischer Arthritis (RA) von Nutzen sein kann, wenn es in Kombination mit anderen oralen Medikamenten gegen die RA verabreicht wird. Es handelt sich hier um eine randomisierte, doppelblinde, placebokontrollierte Studie. Randomisiert bedeutet, dass die Studienbehandlung per Zufall gewählt wird – etwa wie beim Werfen einer Münze. Doppelblind bedeutet, dass weder die Patienten noch der Prüfarzt wissen werden, welches Studienmedikament die Patienten erhalten. Placebokontrolliert bedeutet, dass die Patienten eventuell eine Tablette einnehmen, die kein Medikament enthält. Die Placebo-Tablette sieht genauso aus wie die Filgotinib-Tablette. Die Filgotinib-Tabletten sowie das passende Placebo werden von Gilead Sciences, Inc., dem Auftraggeber dieser Studie, zur Verfügung gestellt. Die Teilnahme an der Studie wird bis zu 28 Wochen dauern, den Voruntersuchungstermin nicht eingeschlossen. In dieser Zeit müssen die Patienten das Prüfzentrum mindestens 10-mal aufsuchen.

Malattie studiate(Fonte di dati: BASEC)

mittelschwere bis stark aktive rheumatoide Arthritis

Health conditions (Fonte di dati: WHO)

Rheumatoid Arthritis

Malattia rara (Fonte di dati: BASEC)

No

Interventi esaminati (p. es. medicamento, terapia, campagna) (Fonte di dati: BASEC)

Teilnehmer werden eine der folgenden Behandlungen erhalten:
- einmal täglich Filgotinib 100 mg
- einmal täglich Filgotinib 200 mg
- einmal täglich Placebo.

Die Wahrscheinlichkeit, eine dieser Behandlungen zu erhalten, ist gleich und beträgt 1 zu 3.

Interventions (Fonte di dati: WHO)

Drug: Filgotinib;Drug: Placebo to match filgotinib;Drug: csDMARDs

Criteri per la partecipazione alla sperimentazione (Fonte di dati: BASEC)

- Männliche oder weibliche Patienten im Alter von ≥ 18 Jahren;
- mittelschwere bis stark aktive rheumatoide Arthritis;
- Vorliegen von ≥ 6 geschwollenen Gelenken;
- eine stabile laufende Behandlung der rheumatoiden Arthritis (nur bestimmte Medikamente zulässig).

Criteri di esclusione (Fonte di dati: BASEC)

- Vorbehandlung mit bestimmten Medikamenten;
- Impfung mit lebenden oder abgeschwächten Impfstoffen 30 Tage vor der Studienteilnahme oder eine geplante Impfung während der Teilnahme;
- chirurgische Behandlungen der rheumatoiden Arthritis von mehr als 4 Gelenken und/oder innerhalb von 12 Wochen vor Beginn der Studienteilnahme;
- Teilnahme an anderen Studien innerhalb von 4 Wochen vor Beginn der Studienteilnahme;
- andere unkontrollierte chronische Erkrankungen (z. B. Diabetes, Bluthochdruck, etc.)
- mittelschwere bis schwere Herzerkrankungen (z.B. Herzversagen, Schlaganfall, Herzinfarkt), bis zu 6 Monate vor dem Beginn der Studienteilnahme;
- eine größere Operation bis zu 12 Wochen vor dem Beginn der Studienteilnahme;
- andere schwere Erkrankungen oder Erkrankungen, die die Auswertung der Studienuntersuchungen stören können.

Inclusion/Exclusion Criteria (Fonte di dati: WHO)


Key Inclusion Criteria:

- Have a diagnosis of RA (2010 ACR/EULAR criteria for RA), and are ACR functional class
I-III.

- Have = 6 swollen joints (from a swollen joint count based on 66 joints (SJC66)) and =6
tender joints (from a tender joint count based on 68 joints (TJC68)) at screening and
Day 1

- Ongoing treatment with a stable prescription of 1 or 2 csDMARDs

- Have received at least one biologic disease modifying antirheumatic drug (bDMARD) for
the treatment of RA to which they have had an inadequate response or intolerance

Key Exclusion Criteria:

- Previous treatment with any janus kinase (JAK) inhibitor

NOTE: Other protocol Inclusion/ Exclusion criteria may apply.

Altri dati sulla sperimentazione nel registro primario dell’OMS

https://clinicaltrials.gov/show/NCT02873936

Altri dati sulla sperimentazione dalla banca dati dell’OMS (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT02873936
Altre informazioni sulla sperimentazione

Data di registrazione della sperimentazione

17 ago 2016

Inserimento del primo partecipante

27 lug 2016

Stato di reclutamento

Completed

Titolo scientifico (Fonte di dati: WHO)

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 Weeks in Combination With Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment

Tipo di sperimentazione (Fonte di dati: WHO)

Interventional

Disegno della sperimentazione (Fonte di dati: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).

Fase (Fonte di dati: WHO)

Phase 3

Punti finali primari (Fonte di dati: WHO)

Proportion of Participants who Achieve an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12

Punti finali secondari (Fonte di dati: WHO)

Proportion of Participants who Achieve Disease Activity Score based on 28 joints (DAS28) (C-reactive protein (CRP)) = 3.2 at Week 12;Change from Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12;Proportion of Participants who Achieve ACR 50% Improvement (ACR50) at Weeks 4, 12, and 24;Proportion of Participants who Achieve ACR 70% Improvement (ACR70) at Weeks 4, 12, and 24;Proportion of Participants who Achieve ACR20 at Weeks 4 and 24;Proportion of Participants who Achieve ACR20 Over Time from Day 1 through Week 24;Proportion of Participants who Achieve ACR50 Over Time from Day 1 through Week 24;Proportion of Participants who Achieve ACR70 Over Time from Day 1 through Week 24;Change from Baseline in Individual Components of the ACR Response at Weeks 4, 12, and 24 and Over Time from Day 1 through Week 24;Proportion of Participants who Achieve Change in HAQ-DI of = 0.22 at Weeks 4, 12, and 24, and Over Time from Day 1 through Week 24;Change from Baseline in DAS28 (CRP) at Weeks 4, 12, and 24, and Over Time from Day 1 through Week 24;Proportion of Participants who Achieve DAS28 (CRP) = 3.2 at Weeks 4, and 24, and Over Time from Day 1 through Week 24;Proportion of Participants who Achieve DAS28 (CRP) < 2.6 at Weeks 4, and 24, and Over Time from Day 1 through Week 24;American College of Rheumatology N (ACR-N) at Weeks 4, 12, and 24, and Over Time from Day 1 through Week 24;European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24, and Over Time from Day 1 through Week 24;Change from Baseline in Clinical Diagnostic Activity Index (CDAI) at Weeks 4, 12, and 24, and Over Time from Day 1 through Week 24;Change from Baseline in Simplified Diagnostic Activity Index (SDAI) at Weeks 4, 12, and 24, and over time from Day 1 through Week 24;Absolute Value and Change from Baseline in Short-form Health Survey (SF-36) at Weeks 4, 12 and 24, and Over Time from Day 1 through Week 24;Absolute Value and Change from Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) at Weeks 4, 12 and 24, and Over Time from Day 1 through Week 24;Absolute Value and Change from Baseline in the EuroQol 5 Dimensions (EQ-5D) Patient-Reported Outcomes Survey at Weeks 4, 12 and 24, and Over Time from Day 1 through Week 24;Absolute Value and Change from Baseline in Work Productivity and Activity Impairment- Rheumatoid Arthritis (WPAI-RA) at Weeks 4, 12, 24, and Over Time from Day 1 through Week 24

Contatto per informazioni (Fonte di dati: WHO)

Please refer to primary and secondary sponsors

Risultati della sperimentazione (Fonte di dati: WHO)

Sintesi dei risultati

ancora nessuna informazione disponibile

Collegamento ai risultati nel registro primario

ancora nessuna informazione disponibile

Informazioni sulla disponibilità dei dati dei singoli partecipanti

ancora nessuna informazione disponibile

Siti di esecuzione della sperimentazione

Siti di esecuzione in Svizzera (Fonte di dati: BASEC)

San Gallo

Paesi di esecuzione (Fonte di dati: WHO)

Argentina, Australia, Belgium, France, Germany, Hungary, Israel, Italy, Japan, Korea, Mexico, Netherlands, Poland, Republic of, Spain, Switzerland, United Kingdom, United States

Contatto per maggiori informazioni sulla sperimentazione

Dati della persona di contatto in Svizzera (Fonte di dati: BASEC)

PD Dr. med. Rüdiger Müller
+41 71 4941138
ruediger.mueller@kssg.ch

Contatto per informazioni generali (Fonte di dati: WHO)

Gilead Study Director
Gilead Sciences

Contatto per informazioni scientifiche (Fonte di dati: WHO)

Gilead Study Director
Gilead Sciences

Autorizzazione da parte della commissione d’etica (Fonte di dati: BASEC)

Nome della commissione d’etica che rilascia l’autorizzazione (nel caso di studi multicentrici solo la commissione direttiva)

Ethikkommission Ostschweiz (EKOS)

Data di autorizzazione da parte della commissione d’etica

11.04.2017

Altri numeri di identificazione delle sperimentazioni

Numero di identificazione della sperimentazione della commissione d’etica (BASEC-ID) (Fonte di dati: BASEC)

2017-00215

Secondary ID (Fonte di dati: WHO)

2016-000569-21
GS-US-417-0302
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