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

• Register: ClinicalTrials.gov
• Last refreshed on: 20 February 2023
• Main ID: NCT02065700
• Date of registration: 14/02/2014
• Prospective Registration: Yes
• Primary sponsor: Galapagos NV
• Public title: Long-term Follow-up Study of GLPG0634 in Active Rheumatoid Arthritis Patients DARWIN3
• Scientific 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
• Date of first enrolment: February 25, 2014
• Target sample size: 739
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02065700
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Argentina, Australia, Belgium, Bulgaria, Chile, Colombia, Czech Republic, Czechia, France, Germany, Guatemala, Hungary, Israel, Latvia, Mexico, Moldova, Republic of, New Zealand, Poland, Romania, Russian Federation, Spain, Ukraine, United States

Contacts

• Name: Galapagos Study Director
• Affiliation: Galapagos NV

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Filgotinib

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

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)]

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 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 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 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 ACR70 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 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)]

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]

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]

Secondary ID(s)

GLPG0634-CL-205

2012-003655-11

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Gilead Sciences