Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of life

Phase 1

• Conditions: moderately to severely active rheumatoid arthritis; MedDRA version: 18.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2012-003655-11-FR
• Lead Sponsor: Galapagos NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-28
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 600

Inclusion Criteria

To be eligible for study entry subjects must fulfil all of the following criteria:
1. Male or female subjects who are =18 years of age, having completed one of the qualifying core studies GLPG0634-CL-203 or GLPG0634-CL-204 and who may benefit from GLPG0634 long-term treatment according to the investigator’s judgment.
2. Females of childbearing potential must accept to continue using adequate contraception during the study and for at least 12 weeks after the last dose of study medication (or longer if required by local regulations), is not lactating, and has had a negative urine pregnancy test on the Entry Visit.
3. Sexually active men must agree to use a medically acceptable form of contraception (double barrier) during the study and continue its use for at least 12 weeks after the last dose of study medication.
4. Able and willing to sign the informed consent as approved by the Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the Entry visit and agree to the schedule of assessments.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 480
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

Subjects will be excluded from the study if one or more of the following statements are applicable:
1. Subjects who had been prematurely withdrawn from one of the 2 core studies (GLPG0634-CL-203 or GLPG0634-CL-204), for any reason.
2. Persistent abnormal laboratory values, associated with the use of the study medication during one of the 2 core studies (GLPG0634-CL-203 and GLPG0634-CL-204), according to the investigator’s clinical judgment.
3. Diagnosis since the last visit (previous visit of studies GLPG0634-CL-203 or GLPG0634-CL-204) of rheumatic autoimmune disease or inflammatory joint disease other than RA, except for secondary Sjögren’s syndrome.
4. Any condition or circumstances which, in the opinion of the investigator, may make a subject unlikely or unable to complete the study or comply with study procedures and requirements.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified