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Safety and Preliminary Efficacy of GLPG0634 in Methotrexate-refractory Active Rheumatoid Arthritis Patients

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 2

Locations

Moldova, Republic of

Study Type

Interventional

Intervention

GLPG0634

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring methotrexate-refractory

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Have active RA as shown by five or more swollen joints (from the 66-joint count), five or more tender joints (from 68-joint count), and a serum CRP ≥1.0 mg/dL;
Have received methotrexate for six months or longer and at a stable dose of 7.5 to 25 mg/week (extremes included) for at least four weeks prior to screening and willing to continue on this regimen for the duration of the study;
If taking oral steroids, these should be at a dose ≤10 mg/day of prednisone or prednisone equivalent and stable for at least four weeks prior to screening;
If taking non-steroidal anti-inflammatory drugs (NSAIDs), these must be at a stable dose for at least two weeks prior to screening;
Female subjects must have a negative pregnancy test unless they are surgically sterile or have been post-menopausal for at least one year (12 consecutive months without menses);
Women of childbearing potential must use a medically acceptable means of birth control and agree to continue its use during the study and for at least four weeks after the last dose of study drug. Sexually active men must agree to use a medically acceptable form of contraception during the study and continue its use for at least 3 months after the last dose of study drug; and
Able and willing to sign the informed consent prior to screening evaluations and agree to schedule of assessments.

Exclusion Criteria:

Treatment with disease-modifying antirheumatic drugs (DMARDs), other than background methotrexate;
Current or previous RA treatment with a biological agent, with the exception of biologics administered in a clinical study setting more than six months prior to screening (12 months for rituximab or other B cell depleting agents);
Previous treatment at any time with a cytotoxic agent, other than methotrexate, before screening;
Receipt of an intra-articular or parenteral corticosteroid injection within four weeks prior to screening;
Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the Investigator, such as anaphylaxis, requiring hospitalization;
Positive serology for human immunodeficiency virus (HIV)1 or 2 or hepatitis B or C, or any history of hepatitis from any cause with the exception of hepatitis A;
History of any inflammatory rheumatological disorders other than RA;
History of tuberculosis (TB) infection;
Pregnant or lactating women.

Sites / Locations

Innophar MO S.R.L.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

GLPG0634 100 mg bid oral capsules

GLPG0634 200 mg qd oral capsules

Placebo oral capsules

Arm Description

Outcomes

Primary Outcome Measures

The number of patients with an ACR20 score at Week 4 as a measure of efficacy

To preliminarily evaluate the efficacy of GLPG0634 compared to placebo in terms of the proportion of subjects achieving an ACR20 response at Week 4

Secondary Outcome Measures

The number of patients with ACR20/50/70 response, time to response and DAS28 score at every visit as a measure of efficacy

To evaluate the efficacy of GLPG0634 compared to placebo in terms of ACR response criteria at every visit (ACR20, ACR50, ACR70), time to response, and disease status (DAS28[C-reactive protein, CRP]

The number of patients with adverse events, abnormal lab tests, vital signs and ECG as a measure of safety and tolerability

To evaluate the safety and tolerability of GLPG0634 in comparison with placebo in terms of adverse events (AEs), laboratory test abnormalities, vital signs and electrocardiogram (ECG)

The plasma levels of GLPG0634 as a measure of PK and the levels of immune- and inflammation-related parameters in blood as a measure of PD

To characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0634 in subjects with rheumatoid arthritis (RA)

Full Information

NCT ID

NCT01384422

First Posted

June 27, 2011

Last Updated

August 14, 2012

Sponsor

Galapagos NV

1. Study Identification

Unique Protocol Identification Number

NCT01384422

Brief Title

Safety and Preliminary Efficacy of GLPG0634 in Methotrexate-refractory Active Rheumatoid Arthritis Patients

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Galapagos NV

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Thirty six patients suffering from active rheumatoid arthritis despite continued treatment with methotrexate will be evaluated for improvement of disease activity when taking GLPG0634 or matching placebo for 4 weeks. During the course of the study, patients will also be examined for any side effects that may occur, and the amount of GLPG0634 present in the blood as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood will be determined.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

methotrexate-refractory

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GLPG0634 100 mg bid oral capsules

Arm Type

Experimental

Arm Title

GLPG0634 200 mg qd oral capsules

Arm Type

Experimental

Arm Title

Placebo oral capsules

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

GLPG0634

Primary Outcome Measure Information:

Title

The number of patients with an ACR20 score at Week 4 as a measure of efficacy

Description

To preliminarily evaluate the efficacy of GLPG0634 compared to placebo in terms of the proportion of subjects achieving an ACR20 response at Week 4

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

The number of patients with ACR20/50/70 response, time to response and DAS28 score at every visit as a measure of efficacy

Description

To evaluate the efficacy of GLPG0634 compared to placebo in terms of ACR response criteria at every visit (ACR20, ACR50, ACR70), time to response, and disease status (DAS28[C-reactive protein, CRP]

Title

The number of patients with adverse events, abnormal lab tests, vital signs and ECG as a measure of safety and tolerability

Description

To evaluate the safety and tolerability of GLPG0634 in comparison with placebo in terms of adverse events (AEs), laboratory test abnormalities, vital signs and electrocardiogram (ECG)

Title

The plasma levels of GLPG0634 as a measure of PK and the levels of immune- and inflammation-related parameters in blood as a measure of PD

Description

To characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0634 in subjects with rheumatoid arthritis (RA)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have active RA as shown by five or more swollen joints (from the 66-joint count), five or more tender joints (from 68-joint count), and a serum CRP ≥1.0 mg/dL; Have received methotrexate for six months or longer and at a stable dose of 7.5 to 25 mg/week (extremes included) for at least four weeks prior to screening and willing to continue on this regimen for the duration of the study; If taking oral steroids, these should be at a dose ≤10 mg/day of prednisone or prednisone equivalent and stable for at least four weeks prior to screening; If taking non-steroidal anti-inflammatory drugs (NSAIDs), these must be at a stable dose for at least two weeks prior to screening; Female subjects must have a negative pregnancy test unless they are surgically sterile or have been post-menopausal for at least one year (12 consecutive months without menses); Women of childbearing potential must use a medically acceptable means of birth control and agree to continue its use during the study and for at least four weeks after the last dose of study drug. Sexually active men must agree to use a medically acceptable form of contraception during the study and continue its use for at least 3 months after the last dose of study drug; and Able and willing to sign the informed consent prior to screening evaluations and agree to schedule of assessments. Exclusion Criteria: Treatment with disease-modifying antirheumatic drugs (DMARDs), other than background methotrexate; Current or previous RA treatment with a biological agent, with the exception of biologics administered in a clinical study setting more than six months prior to screening (12 months for rituximab or other B cell depleting agents); Previous treatment at any time with a cytotoxic agent, other than methotrexate, before screening; Receipt of an intra-articular or parenteral corticosteroid injection within four weeks prior to screening; Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the Investigator, such as anaphylaxis, requiring hospitalization; Positive serology for human immunodeficiency virus (HIV)1 or 2 or hepatitis B or C, or any history of hepatitis from any cause with the exception of hepatitis A; History of any inflammatory rheumatological disorders other than RA; History of tuberculosis (TB) infection; Pregnant or lactating women.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frédéric Vanhoutte, MD

Organizational Affiliation

Galapagos NV

Official's Role

Study Director

Facility Information:

Facility Name

Innophar MO S.R.L.

City

Chisinau

ZIP/Postal Code

MD-2025

Country

Moldova, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

28622463

Citation

Vanhoutte F, Mazur M, Voloshyn O, Stanislavchuk M, Van der Aa A, Namour F, Galien R, Meuleners L, van 't Klooster G. Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Filgotinib, a Selective JAK-1 Inhibitor, After Short-Term Treatment of Rheumatoid Arthritis: Results of Two Randomized Phase IIa Trials. Arthritis Rheumatol. 2017 Oct;69(10):1949-1959. doi: 10.1002/art.40186. Epub 2017 Aug 31.

Results Reference

derived

PubMed Identifier

25681059

Citation

Namour F, Diderichsen PM, Cox E, Vayssiere B, Van der Aa A, Tasset C, Van't Klooster G. Pharmacokinetics and Pharmacokinetic/Pharmacodynamic Modeling of Filgotinib (GLPG0634), a Selective JAK1 Inhibitor, in Support of Phase IIB Dose Selection. Clin Pharmacokinet. 2015 Aug;54(8):859-74. doi: 10.1007/s40262-015-0240-z.

Results Reference

derived

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Safety and Preliminary Efficacy of GLPG0634 in Methotrexate-refractory Active Rheumatoid Arthritis Patients

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