Rheumatoid ArthritisPhase 2NCT01211249
GLPG0259 in Methotrexate-refractory Rheumatoid Arthritis
A Phase 2 study testing GLPG0259 oral capsule and GLPG0259 (Part B) in people with Rheumatoid Arthritis, run by Lakefront Biotherapeutics NV at 32 sites in 5 countries.
Trial summary
Part A: 30 patients suffering from active rheumatoid arthritis despite continued treatment with methotrexate will receive once daily two capsules containing either GLPG0259 (25 mg/capsule) or matching placebo, for 12 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?
- GLPG0259 oral capsule and GLPG0259 (Part B)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 32 sitesin 5 countries
- Study dates
- Oct 2010to Apr 2011
- 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
- Must have active RA (≥5 tender or painful joints on motion and ≥5 joints swollen AND a C-reactive protein (CRP) concentration ≥1.5 mg/dL).
- Must have been on methotrexate for ≥6 months at a stable dose of 7.5-25 mg/week for ≥12 weeks, to be continued throughout study;
- If on oral steroids, these should be at a dose ≤10 mg/day of prednisone eq and stable for ≥4 weeks prior to screening;
- If on NSAIDs, these must be at a stable dose for ≥2 weeks prior to screening;
- Women must have negative pregnancy test unless surgically sterile or post-menopausal for ≥1 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 ≥12 weeks after the last dose of study drug.
- Informed consent
Who cannot join
- Must not have received treatment with DMARDs, other than background methotrexate;
- Must not be receiving or have received RA treatment with a biological agent, except if administered in a clinical study ≥six months prior to screening (12 months for rituximab or other B cell depleting agents);
- Must not have received any treatment with a cytotoxic agent, other than methotrexate, before screening (e.g. chlorambucil, cyclophosphamide, nitrogen mustard, or other alkylating agents);
- Must not have received intra-articular or parenteral corticosteroid injection within four weeks prior to screening;
- Must not regularly be using aspirin or any other anti-coagulant medication;
- Must not have a known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the Investigator, such as anaphylaxis, requiring hospitalization;
Show all 17Show fewer
- Must not have positive serology for human immunodeficiency virus (HIV)1 or 2 or hepatitis B or C, or any history of HIV or hepatitis from any cause with the exception of hepatitis A;
- Must not have a history of any inflammatory rheumatological disorders other than RA;
- Must not have undergone (or planned) surgical treatments for RA;
- Must not have symptoms of clinically significant illness other than RA (including but not limited to cardiopulmonary, renal, metabolic, hematologic, or psychiatric disorders) within three months prior to screening;
- Must not have a history of active infections requiring intravenous antibiotics within the past four weeks;
- Must not have a history of malignancy within the past five years (except for basal cell carcinoma of the skin or carcinoma in situ of the cervix that has been treated with no evidence of recurrence);
- Must not have a history of tuberculosis (TB) infection as determined by a positive diagnostic TB test result (defined as a positive QuantiFERON TB Gold test), AND a recent chest radiograph (both posterior-anterior and lateral views), read by a qualified radiologist, with evidence of current active TB or old inactive TB.
- Must not have been administered a live vaccine within four weeks prior to screening;
- Must not have participated in any investigational drug/device clinical study within four weeks prior to screening, in biological agents clinical studies within six months prior to screening, and B cell-depleting agent clinical studies within 12 months prior to screening;
- Must not have a history within the previous two years or current evidence of drug or alcohol abuse;
- Must not have 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, or may pose a risk to the patient's safety.
Trial locations and contacts
32 sites in 5 countries.
32 sites in 5 countries
Russia13 sites
State Educational Institution of Higher Professional Education "Moscow State Medico-Stomatological University of Roszdrav" State Healthcare Institution of City Moscow "City Clinical Ordena Trudovogo Krasnogo Znameny Hospital #23 n.a. "Medsantrud"
Moscow, 109240
State Healthcare Institution of city Moscow "City Clinical Ordena Trudovogo Krasnogo Znameny Hospital #23 n.a. "Medsantrud"
Moscow, 109240
State Educational Institution of Higher Professional Education "Russian State Medical University of Roszdrav" State Healthcare Institution of City Moscow "City Clinical Hospital #15 n.a. O.M. Filatov"
Moscow, 111539
State Healthcare Institution of City Moscow "City Clinical Hospital #4"
Moscow, 115093
State Healthcare Institution of City Moscow "City Clinical Hospital #7"
Moscow, 115446
Institution Russian Academy of Medical Sciences Scientific Research Institution of Rheumatology RAMN
Moscow, 115522
State Healthcare Institution of City Moscow "City Clinical Hospital #1 n.a. Pirogov"
Moscow, 119049
State Educational Institution of Higher Professional Education "Moscow State Medico-Stomatological University of Roszdrav" at the State Healthcare Institution of city Moscow "City Clinical Ordena Trudovogo Krasnogo Znameny hospital #23 n.a. "M
Moscow, 121374
Saint-Petersburg State Healthcare Institution "City Hospital #26"
Moscow, 196247
Saint-Petersburg State Healthcare Institution "City Pokrovskaya Hospital"
Saint Petersburg, 119106
Saint-Petersburg State Healthcare Institution "City Mariinskiy Hospital"
Saint Petersburg, 191104
Institution of Russian Academy of Sciences Saint-Petersburg Clinical Hospital RAN
Saint Petersburg, 194017
State Educational Institution of Higher Professional Education "Saint-Petersburg State Pediatric Medical Academy of Roszdrav"
Saint Petersburg, 194100
Ukraine10 sites
Chernivtsi Regional Clinical Hospital
Chernivtsi, 58000
Donetsk City Hospital No5
Donetsk, 83000
Kharkiv City Clinical Hospital No.27
Kharkiv, 61002
Kharkiv City Clinical Hospital No.8
Kharkiv, 61176
Kyiv City Clinical Hospital No.3
Kyiv, 02125
Central Pool-type Clinical Hospital MoH of Ukraine
Kyiv, 04053
Institute of Gerontology AMS of Ukraine
Kyiv, 04114
University Clinic, Crimean Medical University
Simferopol, 95006
Vinnytsia Regional Hospital
Vinnytsia, 21018
Zaporizhzhia Regional Hospital
Zaporizhzhya, 69600
Poland5 sites
Specjalistyczne Centrum Medyczne NZOZ NOWOMED
Krakow, 30-349
"Linea Corporis" - Chirurgia Plastyczna Sp. z o.o.
Warsaw, 00-235
Mokotowskie Centrum Osteoporozy S.C.
Warsaw, 02-620
Synexus SCM Sp. z o.o.
Wroclaw, 50-088
Akademia Medyczna im. Piastów Śląskich we Wroclawiu Katedra i Klinika Reumatologii i Chorób Wewnętrznych UM we Wrocławiu
Wroclaw, 50-556
Belgium3 sites
Cliniques Universitaires Saint-Luc
Brussels, 1200
KU Leuven
Leuven, 3000
AZ Alma
Sijsele-Damme, 8340
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled, Multicenter, Exploratory Phase II Study to Compare Three Dose Regimens of GLPG0259 vs Placebo, in Combination With Methotrexate, Administered for 12 Weeks to Subjects With Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate
Part A: 30 patients suffering from active rheumatoid arthritis despite continued treatment with methotrexate will receive once daily two capsules containing either GLPG0259 (25 mg/capsule) or matching placebo, for 12 weeks. In the course of the study the patients will be examined for severity of disease, as well as for any adverse effects that may occur. If needed, dosing may be split to one capsule twice daily, or reduced to one capsule of 25 mg.
Part B: If results of Part A suggest test medication to have a therapeutic advantage over placebo and to be well-tolerated, more patients will be recruited for Part B, where various dosages will be assessed. These dosages will be established based on results from Part A.
- Conditions
- Rheumatoid Arthritis
- Being tested
- GLPG0259 oral capsule, Placebo, GLPG0259 (Part B), Placebo (Part B)
- Keywords
- Methotrexate-refractory
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG0259 oral capsuleDrug
Two capsules, each containing 25 mg of GLPG0259 (i.e. 50 mg/day), to be given once daily; in case of adverse events the dose may be split over two administrations, or reduced to 25 mg/day (one single capsule)
PlaceboDrug
Placebo capsules; two capsules to be taken in the morning, in case of adverse events the dose may be split over two administrations, or reduced to one single capsule
GLPG0259 (Part B)Drug
Capsule, dosage to be established based on results of Part A
Placebo (Part B)Drug
Capsules, dosage to be established after Part A, and matching GLPG0259 (Part B)
| Study group | Role | What they receive |
|---|---|---|
| GLPG0259 (Part A) | Experimental | Not described Receives: Drug: GLPG0259 oral capsule |
| Placebo (Part A) | Placebo comparator | Not described Receives: Drug: Placebo |
| GLPG0259 (Part B) | Experimental | Not described Receives: Drug: GLPG0259 (Part B) |
| Placebo (Part B) | Placebo comparator | Not described Receives: Drug: Placebo (Part B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
The primary efficacy endpoint will be the number and percentage of subjects in each GLPG0259 dose group and placebo group achieving an American College of Rheumatology (ACR)20 (ACR20 response rate) at Week 12.
Measured: 12 weeks
Secondary outcomes (3)
Efficacy
ACR20, ACR50, ACR75 and DAS28 (and components) at weeks 1, 2, 4, 8 and 12;
Measured: intermediate timepoints for 12 weeks
Safety
At each return visit, patients will be asked about adverse events, and undergo examination of heart (ECG) and bloodpressure; blood- and urine-samples will be collected to monitor organ functions.
Measured: 12 weeks
Pharmacokinetics
On several timepoints throughout the study bloodsamples will be taken from the patient to establish the amount of the study medication in the blood, and to determine how long it stays in the blood.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionApr 2011
- Study completionApr 2011
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johan Beetens, PhD, Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01211249
- Sponsor's protocol ID
- GLPG0259-CL-201
- Other IDs
- 2009-015898-12, 2009
- Status last verified
- Apr 2011
- First submitted
- 28 Sep 2010
- Last updated
- 26 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Westhovens R, Keyser FD, Rekalov D, Nasonov EL, Beetens J, Van der Aa A, Wigerinck P, Namour F, Vanhoutte F, Durez P. Oral administration of GLPG0259, an inhibitor of MAPKAPK5, a new target for the treatment of rheumatoid arthritis: a phase II, randomised, double-blind, placebo-controlled, multicentre trial. Ann Rheum Dis. 2013 May;72(5):741-4. doi: 10.1136/annrheumdis-2012-202221. Epub 2012 Nov 17.
PubMed 23161899
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled, Multicenter, Exploratory Phase II Study to Compare Three Dose Regimens of GLPG0259 vs Placebo, in Combination With Methotrexate, Administered for 12 Weeks to Subjects With Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate
- ClinicalTrials.gov ID
- NCT01211249
- Acronym / sponsor ID
- GLPG0259-CL-201
- Conditions
- Rheumatoid Arthritis
- Keywords
- Methotrexate-refractory
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 29 Sep 2010 (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.
Part A: 30 patients suffering from active rheumatoid arthritis despite continued treatment with methotrexate will receive once daily two capsules containing either GLPG0259 (25 mg/capsule) or matching placebo, for 12 weeks. In the course of the study the patients will be examined for severity of disease, as well as for any adverse effects that may occur. If needed, dosing may be split to one capsule twice daily, or reduced to one capsule of 25 mg.
Part B: If results of Part A suggest test medication to have a therapeutic advantage over placebo and to be well-tolerated, more patients will be recruited for Part B, where various dosages will be assessed. These dosages will be established based on results from Part A.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GLPG0259 (Part A) | Experimental | Drug: GLPG0259 oral capsule |
| Placebo (Part A) | Placebo comparator | Drug: Placebo |
| GLPG0259 (Part B) | Experimental | Drug: GLPG0259 (Part B) |
| Placebo (Part B) | Placebo comparator | Drug: Placebo (Part B) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Must have active RA (≥5 tender or painful joints on motion and ≥5 joints swollen AND a C-reactive protein (CRP) concentration ≥1.5 mg/dL).
- Must have been on methotrexate for ≥6 months at a stable dose of 7.5-25 mg/week for ≥12 weeks, to be continued throughout study;
- If on oral steroids, these should be at a dose ≤10 mg/day of prednisone eq and stable for ≥4 weeks prior to screening;
- If on NSAIDs, these must be at a stable dose for ≥2 weeks prior to screening;
- Women must have negative pregnancy test unless surgically sterile or post-menopausal for ≥1 year;
Key exclusion criteria (17 listed)
- Must not have received treatment with DMARDs, other than background methotrexate;
- Must not be receiving or have received RA treatment with a biological agent, except if administered in a clinical study ≥six months prior to screening (12 months for rituximab or other B cell depleting agents);
- Must not have received any treatment with a cytotoxic agent, other than methotrexate, before screening (e.g. chlorambucil, cyclophosphamide, nitrogen mustard, or other alkylating agents);
- Must not have received intra-articular or parenteral corticosteroid injection within four weeks prior to screening;
- Must not regularly be using aspirin or any other anti-coagulant medication;
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 |
|---|---|---|
| GLPG0259 oral capsuleTwo capsules, each containing 25 mg of GLPG0259 (i.e. 50 mg/day), to be given once daily; in case of adverse events the dose may be split over two administrations, or reduced to 25 mg/day (one single capsule) | Drug | GLPG0259 (Part A) |
| PlaceboPlacebo capsules; two capsules to be taken in the morning, in case of adverse events the dose may be split over two administrations, or reduced to one single capsule | Drug | Placebo (Part A) |
| GLPG0259 (Part B)Capsule, dosage to be established based on results of Part A | Drug | GLPG0259 (Part B) |
| Placebo (Part B)Capsules, dosage to be established after Part A, and matching GLPG0259 (Part B) | Drug | Placebo (Part B) |
Primary outcome
Efficacy
Time frame: 12 weeks
The primary efficacy endpoint will be the number and percentage of subjects in each GLPG0259 dose group and placebo group achieving an American College of Rheumatology (ACR)20 (ACR20 response rate) at Week 12.
3 secondary outcomes
Efficacy
Time frame: intermediate timepoints for 12 weeks
Safety
Time frame: 12 weeks
Pharmacokinetics
Time frame: 12 weeks
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 26 Apr 2011.
- Derived from this study: PubMed 23161899Westhovens R, Keyser FD, Rekalov D, Nasonov EL, Beetens J, Van der Aa A, Wigerinck P, Namour F, Vanhoutte F, Durez P. Oral administration of GLPG0259, an inhibitor of MAPKAPK5, a new target for the treatment of rheumatoid arthritis: a phase II, randomised, double-blind, placebo-controlled, multicentre trial. Ann Rheum Dis. 2013 May;72(5):741-4. doi: 10.1136/annrheumdis-2012-202221. Epub 2012 Nov 17.
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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.
Johan Beetens, PhD study director
Lakefront Biotherapeutics NV
32 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GLPG0259 oral capsule and GLPG0259 (Part B) in people with Rheumatoid Arthritis, run by Lakefront Biotherapeutics NV at 32 sites in 5 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 7 inclusion and 17 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 26 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Russia, Ukraine, Poland, Belgium, Netherlands. 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?
Efficacy (time frame: 12 weeks). 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 NCT01211249, 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 26 Apr 2011.