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: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-11
• Last Update Posted: 21 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 739

Inclusion Criteria

The principle inclusion criteria are:
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 in the opinion of the investigator, will continue to benefit
from treatment in the extension study.
2. Females of childbearing potential must continue using highly effective
methods of birth control during the study and for at least 12 weeks after
the last dose of study medication (or longer if required by local
regulations).
3-Sexually active men must agree to use a highly effective method of
contraception (e.g. double barrier) during the study and continue its use
for at least 12 weeks after the last dose of study medication.
Please see study protocol for full details
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

The principle exclusion criteria are:
1-Subjects who had been prematurely withdrawn from one of the 2 core
studies
(GLPG0634-CL-203 or GLPG0634-CL-204), for any reason, including
fulfilling the individual stopping criteria.
2. Subjects who are deemed not to be benefiting from the study
medication based
upon lack of improvement or worsening of their symptoms. Local
guidelines for subject treatment need to be followed.
3. Subjects with persistent abnormal laboratory values, associated with
the use of
the study medication (including but not limited to hematology, liver and
renal function values) during one of the 2 core studies (GLPG0634-CL-
203 and GLPG0634-CL-204), according to the investigator's clinical
judgment.
Please see study protocol for full details

Study & Design

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