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Long-term Follow-up Study of GLPG0634 in Active Rheumatoid Arthritis Patients (DARWIN3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02065700
Recruitment Status : Active, not recruiting
First Posted : February 19, 2014
Last Update Posted : July 2, 2021
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Galapagos NV

Tracking Information
First Submitted Date  ICMJE February 14, 2014
First Posted Date  ICMJE February 19, 2014
Last Update Posted Date July 2, 2021
Actual Study Start Date  ICMJE February 25, 2014
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2018)
Safety and Tolerability of Long-Term Dosing of Filgotinib as Assessed by the Percentage of Participants Experiencing Treatment-Emergent Adverse Events [ Time Frame: Approximately 96 months, from Entry Visit (last visit from the previous core study, GLPG0634-CL-203 or GLPG0634-CL-204) to Final Visit (last dose) plus 2 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 15, 2014)
The number of subjects with adverse events, and the changes from baseline in laboratory parameters, vital signs, physical exam and ECG [ Time Frame: Approximately 60 months, from Entry Visit (last visit from the previous core study, GLPG0634-CL-204 or GLPG0634-CL-204) until Follow-up visit 2 weeks after last dose ]
To evaluate long-term safety and tolerability of GLPG0634 in terms of adverse events, laboratory parameters, vital signs, physical exam and electrocardiograms (ECG)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2018)
  • Percentage of Participants Achieving American College of Rheumatology (ACR)20 Response at Every Visit [ Time Frame: Approximately 96 months, from Entry Visit to Final Visit (last dose), every 12 weeks ]
  • Percentage of Participants Achieving ACR50 Response at Every Visit [ Time Frame: Approximately 96 months, from Entry Visit to Final Visit (last dose), every 12 weeks ]
  • Percentage of Participants Achieving ACR70 Response at Every Visit [ Time Frame: Approximately 96 months, from Entry Visit to Final Visit (last dose), every 12 weeks ]
  • Percentage of Participants Achieving ACR-N Response at Every Visit [ Time Frame: Approximately 96 months, from Entry Visit to Final Visit (last dose), every 12 weeks ]
  • Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response at Every Visit [ Time Frame: Approximately 96 months, from Entry Visit to Final Visit (last dose), every 12 weeks ]
  • Percentage of Participants Achieving ACR/EULAR Remission at Every Visit [ Time Frame: Approximately 96 months, from Entry Visit to Final Visit (last dose), every 12 weeks ]
  • Percentage of Participants Achieving a Clinical Disease Activity Index (CDAI) Response at Every Visit [ Time Frame: Approximately 96 months, from Entry Visit to Final Visit (last dose), every 12 weeks ]
  • Percentage of Participants Achieving a Simplified Disease Activity Index (SDAI) Response at Every Visit [ Time Frame: Approximately 96 months, from Entry Visit to Final Visit (last dose), every 12 weeks ]
  • Percentage of Participants Achieving a Disease Activity Score Based on 28 Joints and C-Reactive Protein (DAS28-CRP) Response at Every Visit [ Time Frame: Approximately 96 months, from Entry Visit to Final Visit (last dose), every 12 weeks ]
  • Quality of Life: Change from Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Every 48 Weeks [ Time Frame: Baseline to approximately 96 months, every 48 weeks until Final Visit (last dose) ]
  • Quality of Life: Change from Baseline in the 36-Item Short Form Health Survey (SF-36) Score every 48 Weeks [ Time Frame: Baseline to approximately 96 months, every 48 weeks until Final Visit (last dose) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2014)
  • Percentage of subjects achieving American College of Rheumatology (ACR)20 response at every visit [ Time Frame: Approximately 60 months, from Entry visit to Final visit (last dose), every 12 weeks ]
  • Percentage of subjects achieving American College of Rheumatology (ACR)50 response at every visit [ Time Frame: Approximately 60 months, from Entry visit to Final visit (last dose), every 12 weeks ]
  • Percentage of subjects achieving American College of Rheumatology (ACR)70 response at every visit [ Time Frame: Approximately 60 months, from Entry visit to Final visit (last dose), every 12 weeks ]
  • Percentage of subjects achieving American College of Rheumatology (ACR)-N response at every visit [ Time Frame: Approximately 60 months, from Entry visit to Final visit (last dose), every 12 weeks ]
  • Percentage of subjects achieving European League Against Rheumatism (EULAR) response at every visit [ Time Frame: Approximately 60 months, from Entry visit to Final visit (last dose), every 12 weeks ]
  • Percentage of subjects achieving ACR/EULAR remission at every visit [ Time Frame: Approximately 60 months, from Entry visit to Final visit (last dose), every 12 weeks ]
  • Percentage of subjects achieving a Clinical Disease Activity Index (CDAI) response at every visit [ Time Frame: Approximately 60 months, from Entry visit to Final visit (last dose), every 12 weeks ]
  • Percentage of subjects achieving a Simplified Disease Activity Index (SDAI) response at every visit [ Time Frame: Approximately 60 months, from Entry visit to Final visit (last dose), every 12 weeks ]
  • Percentage of subjects achieving a Disease Activity Score based on 28 joints and c-reactive protein (DAS28-CRP) response at every visit [ Time Frame: Approximately 60 months, from Entry visit to Final visit (last dose), every 12 weeks ]
  • Change in the functional assessment of chronic illness therapy (FACIT) score every 48 weeks [ Time Frame: Approximately 60 months, every 48 weeks until Final visit (last dose) ]
    To evaluate the Quality of Life by means of the FACIT score
  • Change in the 36-item short form health survey (SF-36) score every 48 weeks [ Time Frame: Approximately 60 months, every 48 weeks until Final visit (last dose) ]
    To evaluate the Quality of Life by means of the SF-36 score
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-term Follow-up Study of GLPG0634 in Active Rheumatoid Arthritis Patients
Official Title  ICMJE A Multicenter, Open-label, Long-term Follow-up Safety and Efficacy Study of GLPG0634 Treatment in Subjects With Moderately to Severely Active Rheumatoid Arthritis
Brief Summary

The primary objective of the study is to evaluate the long-term safety and tolerability of filgotinib (formerly GLPG0634) for the treatment of rheumatoid arthritis.

Participants will be enrolled in this open-label long-term follow-up study after they have completed one of the two core studies, GLPG0634-CL-203 (DARWIN1) or GLPG0634-CL-204 (DARWIN2), and will be evaluated for any side effects that may occur (long-term safety and tolerability) when taking filgotinib. During the course of the study, participants will also be examined for long-term effects of filgotinib administration on disease activity (efficacy), subjects' disability, fatigue, and quality of life.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE Drug: Filgotinib
Tablets administered orally
Other Names:
  • GS-6034
  • GLPG0634
Study Arms  ICMJE
  • Experimental: Filgotinib 200 mg once daily
    Filgotinib 200 mg (2 x 100 mg) once daily (morning)
    Intervention: Drug: Filgotinib
  • Experimental: Filgotinib 100 mg twice daily
    Filgotinib 100 mg twice daily (morning and evening)
    Intervention: Drug: Filgotinib
Publications * Kavanaugh A, Westhovens RR, Winthrop KL, Lee SJ, Tan Y, An D, Ye L, Sundy JS, Besuyen R, Meuleners L, Stanislavchuk M, Spindler AJ, Greenwald M, Alten R, Genovese MC. Safety and Efficacy of Filgotinib: Up to 4-year Results From an Open-label Extension Study of Phase II Rheumatoid Arthritis Programs. J Rheumatol. 2021 Aug;48(8):1230-1238. doi: 10.3899/jrheum.201183. Epub 2021 Feb 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 12, 2017)
739
Original Estimated Enrollment  ICMJE
 (submitted: February 15, 2014)
600
Estimated Study Completion Date  ICMJE May 2023
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Male or female who are 18 years of age or older on the day of signing informed consent
  • Participants who completed one of the qualifying core studies GLPG0634-CL-203 or GLPG0634-CL-204 and may benefit from filgotinib long-term treatment according to the Investigator's judgment
  • Females of childbearing potential and sexually active men must agree to use highly effective method of birth control as specified in the protocol, during the study and for at least 12 weeks after the last dose of filgotinib

Key Exclusion Criteria:

  • Participants who prematurely withdrew from one of the 2 core studies (GLPG0634-CL-203 or GLPG0634-CL-204), for any reason
  • Persistent abnormal lab values during one of the 2 core studies (GLPG0634-CL-203 or GLPG0634-CL-204), according to the Investigator's judgment
  • Diagnosis of rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis, except for secondary Sjogren's syndrome
  • Any condition or circumstances which, in the opinion of the Investigator, may make a participant unlikely or unable to complete the study or comply with study procedures and requirements

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Bulgaria,   Chile,   Colombia,   Czechia,   France,   Germany,   Guatemala,   Hungary,   Israel,   Latvia,   Mexico,   Moldova, Republic of,   New Zealand,   Poland,   Romania,   Russian Federation,   Spain,   Ukraine,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02065700
Other Study ID Numbers  ICMJE GLPG0634-CL-205
2012-003655-11 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Galapagos NV
Study Sponsor  ICMJE Galapagos NV
Collaborators  ICMJE Gilead Sciences
Investigators  ICMJE
Study Director: Galapagos Study Director Galapagos NV
PRS Account Galapagos NV
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP