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

• ClinicalTrials.gov Identifier: NCT02065700
• Recruitment Status: Active, not recruiting
• First Posted: February 19, 2014
• Last Update Posted: July 2, 2021
• Sponsor: Galapagos NV
• Collaborator: Gilead Sciences
• Information provided by (Responsible Party): Galapagos NV

Tracking Information

• First Submitted Date: February 14, 2014
• First Posted Date: February 19, 2014
• Last Update Posted Date: July 2, 2021
• Actual Study Start Date: February 25, 2014
• Estimated Primary Completion Date: May 2023 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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 (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)

Current Secondary Outcome Measures (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 (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: Long-term Follow-up Study of GLPG0634 in Active Rheumatoid Arthritis Patients
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Rheumatoid Arthritis

Intervention

Drug: Filgotinib

Tablets administered orally

Other Names:

• GS-6034
• GLPG0634

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: January 12, 2017): 739
• Original Estimated Enrollment (submitted: February 15, 2014): 600
• Estimated Study Completion Date: May 2023
• Estimated Primary Completion Date: May 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: 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: NCT02065700
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Galapagos NV
• Study Sponsor: Galapagos NV
• Collaborators: Gilead Sciences

Investigators

• Study Director: Galapagos Study Director; Galapagos NV

• PRS Account: Galapagos NV
• Verification Date: June 2021