Rheumatoid ArthritisPhase 2NCT01668641
Dose-ranging Study With GLPG0634 in Methotrexate-refractory Active Rheumatoid Arthritis Patients
A Phase 2 study testing GLPG0634 in people with Rheumatoid Arthritis, run by Lakefront Biotherapeutics NV at 19 sites in 4 countries.
Trial summary
Ninety patients suffering from active rheumatoid arthritis despite continued treatment with methotrexate will be evaluated for improvement of disease activity when taking GLPG0634 (4 different doses will be evaluated) or matching placebo for 4 weeks. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- GLPG0634
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 19 sitesin 4 countries
- Study dates
- May 2012to Oct 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 12 weeks or longer and at a stable dose of 7.5 to 25 mg/week for at least 4 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 4 weeks prior to screening;
- If taking non-steroidal anti-inflammatory drugs (NSAIDs), these must be at a stable dose for at least 2 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;
- 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 12 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.
Who cannot join
- 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;
- Previous use of the study drug GLPG0634;
- Receipt of an intra-articular or parenteral corticosteroid injection within 4 weeks prior to screening;
- Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the Investigator;
Show all 9Show fewer
- Positive serology for HIV1 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
Trial locations and contacts
19 sites in 4 countries.
19 sites in 4 countries
Ukraine9 sites
Chernivtsi Regional Clinical Hospital
Chernivtsi
State Institution 'Institute of Urgent and Recovery Surgery n.a. V.K. Gusaka' of AMS of Ukraine
Donetsk
Communal Institution of Healthcare
Kharkiv
Institution of Therapy of AMS of Ukraine
Kharkiv
State Institution 'Institute of Microbiology and Immunology of AMS of Ukraine'
Kharkiv
State Institution 'Republican Clinical Hospital of MoH of Ukraine'
Kiev
Lutsk City Clinical Hospital
Lutsk
Vinnytsa Regional Clinical Hospital
Vinnytsa
Zaporizhzhia Regional Clinical Hospital
Zaporizhzhya
Russia5 sites
State Healthcare Institution of city Moscow 'City Clinical Hospital #7'
Moscow
State Healthcare Institution 'Ryazan Regional Cardiology Dispensary'
Ryazan
Saint-Petersburg State Healthcare Institution 'City Hospital #26'
Saint Petersburg
Saint-Petersburg State Healthcare Institution 'City Mariinskiy Hospital'
Saint Petersburg
Municipal Clinical Healthcare Institution 'Medical-Sanitary Unit of Novoyaroslavskiy Oil Refinery'
Yaroslavl
Hungary4 sites
Budai Irgalamsrendi Korhaz, II. Reumatologia Osztaly
Budapest
Orszagos Reumatologiai es Fizioterapias Intezet, I. Reumatologia Osztaly
Budapest
Markhot Ferenc Korhaz, Reumatologiai Osztaly
Eger
Pest Megyei Flor Ferenc Korhaz, Reumatologiai es Fizioterapias Osztaly
Kistarcsa
About this study
Official title: Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Compare Four Dose Regimens of GLPG0634 Versus Placebo, in Combination With Methotrexate, Administered for 4 Weeks in the Treatment of Subjects With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Alone
- Ninety patients suffering from active rheumatoid arthritis despite continued treatment with methotrexate will be evaluated for improvement of disease activity when taking GLPG0634 (4 different doses will be evaluated) 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- GLPG0634, Placebo
- Keywords
- Methotrexate insufficient responders
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG0634Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| capsule, 30mg GLPG0634 once a day | Experimental | 3 capsules of 10 mg once a day Receives: Drug: GLPG0634 |
| capsules, 75mg GLPG0634 once a day | Experimental | 3 capsules of 25mg once a day Receives: Drug: GLPG0634 |
| capsules, 150mg GLPG0634 once a day | Experimental | 3 capsules of 50mg once a day Receives: Drug: GLPG0634 |
| capsules, 300mg GLPG0634 once a day | Experimental | 3 capsules of 100mg once a day Receives: Drug: GLPG0634 |
| capsules, placebo once a day | Placebo comparator | 3 capsules placebo once a day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with an ACR20 score at Week 4 as a measure of efficacy
To preliminary evaluate the efficacy of GLPG0634 compared to placebo in terms of the proportion of subjects achieving an ACR20 response at Week 4
Measured: Week 4 (end of treatment visit)
Secondary outcomes (5)
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]
Measured: From Day -1 up to end of treatment visit (week 4)
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)
Measured: From screening up to 10 days after last dose
The plasma levels of GLPG0634 as a measure of PK
To characterize the pharmacokinetics (PK) of GLPG0634 by measuring the amount of GLPG0634 in the plasma
Measured: Week 1, week 2 and week 4 visits
The plasma levels of GLPG0634 and MTX as a measure of PK
To explore the potential interaction of GLPG0634 on MTX by assessing steady state PK in an 8-hour sampling at Day -1 and at Week 2 or Week 4 visit in a subset of patients
Measured: Day -1 and Week 2 or 4 visit (8 hour-sampling)
The levels of immune- and inflammation-related parameters in plasma as a measure of PD
To characterize the pharmacodynamics (PD) of GLPG0634 by measuring the levels of immune- and inflammation-related parameters in plasma
Measured: Day -1, Week 1, week 2 and week 4 visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study startMay 2012
- Primary completionSep 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frédéric Vanhoutte, MD, Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668641
- Sponsor's protocol ID
- GLPG0634-CL-202
- Status last verified
- Jun 2013
- First submitted
- 14 Aug 2012
- Last updated
- 27 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28622463
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Compare Four Dose Regimens of GLPG0634 Versus Placebo, in Combination With Methotrexate, Administered for 4 Weeks in the Treatment of Subjects With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Alone
- ClinicalTrials.gov ID
- NCT01668641
- Acronym / sponsor ID
- GLPG0634-CL-202
- Conditions
- Rheumatoid Arthritis
- Keywords
- Methotrexate insufficient responders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 20 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Ninety patients suffering from active rheumatoid arthritis despite continued treatment with methotrexate will be evaluated for improvement of disease activity when taking GLPG0634 (4 different doses will be evaluated) 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| capsule, 30mg GLPG0634 once a day | Experimental | Drug: GLPG06343 capsules of 10 mg once a day |
| capsules, 75mg GLPG0634 once a day | Experimental | Drug: GLPG06343 capsules of 25mg once a day |
| capsules, 150mg GLPG0634 once a day | Experimental | Drug: GLPG06343 capsules of 50mg once a day |
| capsules, 300mg GLPG0634 once a day | Experimental | Drug: GLPG06343 capsules of 100mg once a day |
| capsules, placebo once a day | Placebo comparator | Drug: Placebo3 capsules placebo once a day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 12 weeks or longer and at a stable dose of 7.5 to 25 mg/week for at least 4 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 4 weeks prior to screening;
- If taking non-steroidal anti-inflammatory drugs (NSAIDs), these must be at a stable dose for at least 2 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;
Key exclusion criteria (9 listed)
- 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;
- Previous use of the study drug GLPG0634;
- Receipt of an intra-articular or parenteral corticosteroid injection within 4 weeks prior to screening;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLPG0634 | Drug | capsule, 30mg GLPG0634 once a day, capsules, 150mg GLPG0634 once a day, capsules, 300mg GLPG0634 once a day, capsules, 75mg GLPG0634 once a day |
| Placebo | Drug | capsules, placebo once a day |
Primary outcome
The number of patients with an ACR20 score at Week 4 as a measure of efficacy
Time frame: Week 4 (end of treatment visit)
To preliminary evaluate the efficacy of GLPG0634 compared to placebo in terms of the proportion of subjects achieving an ACR20 response at Week 4
5 secondary outcomes
The number of patients with ACR20/50/70 response, time to response and DAS28 score at every visit as a measure of efficacy
Time frame: From Day -1 up to end of treatment visit (week 4)
The number of patients with adverse events, abnormal lab tests, vital signs and ECG as a measure of safety and tolerability
Time frame: From screening up to 10 days after last dose
The plasma levels of GLPG0634 as a measure of PK
Time frame: Week 1, week 2 and week 4 visits
The plasma levels of GLPG0634 and MTX as a measure of PK
Time frame: Day -1 and Week 2 or 4 visit (8 hour-sampling)
The levels of immune- and inflammation-related parameters in plasma as a measure of PD
Time frame: Day -1, Week 1, week 2 and week 4 visits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2013.
- Derived from this study: PubMed 28622463Vanhoutte 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédéric Vanhoutte, MD study director
Lakefront Biotherapeutics NV
19 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GLPG0634 in people with Rheumatoid Arthritis, run by Lakefront Biotherapeutics NV at 19 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Ukraine, Russia, Hungary, Moldova. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients with an ACR20 score at Week 4 as a measure of efficacy (time frame: Week 4 (end of treatment visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01668641, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2013.