A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of GLPG3970, Administered Orally for 6 Weeks in Adult Subjects With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate
Overview
- Phase
- Phase 2
- Intervention
- GLPG3970
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Galapagos NV
- Enrollment
- 28
- Locations
- 9
- Primary Endpoint
- Change From Baseline in DAS-28 (CRP) at Week 6
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The primary objective of this study was to evaluate the effect of GLPG3970 compared to placebo on the signs and symptoms of Rheumatoid Arthritis (RA) in participants with moderately to severely active RA and an inadequate response to methotrexate (MTX).
Investigators
Eligibility Criteria
Inclusion Criteria
- •A body mass index (BMI) between 18-32 kg/m\^2, inclusive.
- •Diagnosis of RA ≥6 months prior to screening AND meeting the 2010 American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) criteria of RA AND ACR functional class I-III.
- •Have ≥6 swollen joints (from a swollen joint count evaluated in 66 joints \[SJC66\]) AND ≥8 tender joints (from a tender joint count evaluated in 68 joints \[TJC68\]) at screening and at the baseline visit (Visit 1) prior to the first investigational product (IP) dosing.
- •DAS28 (CRP) \>3.2 (moderate disease) at screening.
- •Screening serum high sensitivity C-reactive protein (hsCRP) \> upper limit of normal (ULN, central laboratory reference: ≤ 5.0 mg/L).
- •Inadequate response to MTX, i.e. treatment-experienced participants who demonstrated inadequate clinical response during treatment with MTX.
- •Have received MTX for ≥6 months and on stable dose (10 to 20 mg/week) of MTX for at least 4 weeks prior to screening and willing to continue on their current stable dose and dosing regimen for the duration of the study.
- •If taking systemic steroids, prednisone equivalent at a dose of ≤10 mg/day and stable for at least 4 weeks prior to the first IP dosing.
Exclusion Criteria
- •Current therapy with any conventional disease-modifying antirheumatic drug (DMARD) other than MTX, including
- •oral or injectable gold, sulfasalazine, antimalarials, azathioprine, or D-penicillamine within 4 weeks prior to screening,
- •cyclosporine within 8 weeks prior to screening, and
- •leflunomide within 3 months prior to screening or a minimum 4 weeks prior to screening if after 11 days of standard cholestyramine therapy.
- •Current or previous treatment with a biologic DMARD (bDMARD). Except for participants who received bDMARDs only in a single clinical study setting:
- •For whom the last dose of bDMARD ≥6 months prior to screening (12 months for rituximab or other lymphocyte depleting agents), AND;
- •For whom the bDMARD was effective, without being discontinued due to lack of efficacy.
- •Participants who received an intra-articular or parenteral corticosteroid injection within 4 weeks prior to screening.
- •Participants who received a prior surgical intervention within 12 weeks prior to screening or likely requirement for surgery during the study.
- •Participant has a history of tuberculosis (TB) diagnosis or evidence of active or latent infection with Mycobacterium tuberculosis as defined by one of the following assessments:
Arms & Interventions
GLPG3970
Participants received 400 milligrams (mg) GLPG3970 oral solution, once daily (QD) for a period of 6 weeks.
Intervention: GLPG3970
Placebo
Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks.
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline in DAS-28 (CRP) at Week 6
Time Frame: Baseline and Week 6
The DAS28 (CRP) is a derived measurement with differential weighting given to each component such as TJC28, SJC28, patient's global assessment of disease activity, and serum CRP level. * TJC28 ranges from 0-28 * SJC28 ranges from 0-28 * High sensitivity C-reactive protein (hsCRP) (in mg/L) * Patient's disease activity VAS (in mm) (ranges from 0 = best to 100 = worst) The DAS28 (CRP) score was calculated using the below formula: DAS28 (CRP) = 0.56 x square root of TJC28 + 0.28 x square root of SJC28 + 0.36 x Ln\[1+CRP(in mg/L)\] + 0.014 x patient's disease activity VAS (in mm) + 0.96. A lower score is considered as better disease activity.
Secondary Outcomes
- Number of Participants With Treatment Emergent Adverse Events(From first dose of study drug until end of the study (up to 8 weeks))
- Plasma Concentration (Ctrough) of GLPG3970(Day 15: pre-dose; Day 29: pre-dose; Day 43: pre-dose)