Brief description of trial (Data source: 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.
Health conditions investigated(Data source: BASEC)
mittelschwere bis stark aktive rheumatoide Arthritis
Health conditions
(Data source: WHO)
Rheumatoid Arthritis
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: 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
(Data source: WHO)
Drug: Filgotinib;Drug: Placebo to match filgotinib;Drug: csDMARDs
Criteria for participation in trial
(Data source: 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).
Exclusion criteria
(Data source: 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
(Data source: 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.
-
Further information on trial
Date trial registered
Aug 17, 2016
Incorporation of the first participant
Jul 27, 2016
Recruitment status
Completed
Academic title
(Data source: 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
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
Phase
(Data source: WHO)
Phase 3
Primary end point
(Data source: WHO)
Proportion of Participants who Achieve an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12
Secundary end point
(Data source: 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
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
St. Gallen
Countries
(Data source: WHO)
Argentina, Australia, Belgium, France, Germany, Hungary, Israel, Italy, Japan, Korea, Mexico, Netherlands, Poland, Republic of, Spain, Switzerland, United Kingdom, United States
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
PD Dr. med. Rüdiger Müller
+41 71 4941138
ruediger.mueller@kssg.ch
Contact for general information
(Data source: WHO)
Gilead Study Director
Gilead Sciences
Contact for scientific information
(Data source: WHO)
Gilead Study Director
Gilead Sciences
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Ethikkommission Ostschweiz (EKOS)
Date of authorisation by the ethics committee
11.04.2017
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2017-00215
Secondary ID (Data source: WHO)
2016-000569-21
GS-US-417-0302
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