Rheumatoid ArthritisPhase 2NCT01590459
24-week Study With Open Label Extension of VX-509, an Oral JAK3 Inhibitor, in Subjects Taking Methotrexate
A Phase 2 study testing VX-509 in people with Rheumatoid Arthritis, run by Vertex Pharmaceuticals Incorporated at 94 sites in 14 countries.
Trial summary
This study is designed to evaluate the safety and efficacy of VX-509, an oral JAK3 inhibitor, for treatment of subjects with active RA who have had an inadequate response to Methotrexate. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- VX-509
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 359 participants
- Where
- 94 sitesin 14 countries
- Study dates
- Apr 2012to Jul 2014
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects, between 18 and 80 years of age (inclusive)
- All subjects must have been diagnosed with RA
- Must have a swollen joint count of ≥6 out of 66 joints and tender joint count of ≥6 out of 68 joints
- Baseline CRP level must be above the upper limit of normal
- All subjects must have been receiving stable MTX coadministered with folic or folinic acid (at least 5 mg/week)
- Subjects may remain on 1 nonsteroidal anti-inflammatory medication during the study (aspirin ≤ 325 mg/day is allowed).
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- Subjects must not have received prior treatment with a JAK inhibitor
- Subjects who are on an additional nonbiologic DMARD (e.g., sulfasalazine) must be willing to discontinue that DMARD after signing consent, except for hydroxychloroquine
- Subjects may have received previous therapy with a single TNF inhibitor (e.g., etanercept, adalimumab, infliximab, golimumab, certolizumab pegol)
- Females must have a negative pregnancy test prior to study dosing
- Sexually active subjects and their partners must agree to contraceptive requirements
Who cannot join
- History or presence of a clinically significant medical disorder other than RA that, in the opinion of the investigator and medical monitor, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
- Subjects with inflammatory, rheumatological disorders other than RA
- Pregnant or nursing female subjects
- Subjects who have a female partner who is pregnant, nursing, or planning to become pregnant
- Subjects who have planned major surgery (e.g., joint replacement) or procedures during the study
- History of drug abuse or positive drug screen
- History of alcohol abuse or excessive alcohol consumption
- History of tuberculosis (TB) infection of any kind (pulmonary or extrapulmonary, active or latent), regardless of history of anti-TB treatment.
Trial locations and contacts
94 sites in 14 countries.
94 sites in 14 countries
United States31 sites
Vertex Investigational Site
Austin, Texas
Vertex Investigational Site
Bethlehem, Pennsylvania
Vertex Investigational Site
Birmingham, Alabama
Vertex Investigational Site
Boca Raton, Florida
Vertex Investigational Site
Brooklyn, New York
Vertex Investigational Site
Charlotte, North Carolina
Vertex Investigational Site
Clarksburg, West Virginia
Vertex Investigational Site
Clifton, New Jersey
Vertex Investigational Site
Daytona Beach, Florida
Vertex Investigational Site
Duncansville, Pennsylvania
Vertex Investigational Site
Durham, North Carolina
Vertex Investigational Site
Freehold, New Jersey
Vertex Investigational Site
Hickory, North Carolina
Vertex Investigational Site
Houston, Texas
Vertex Investigational Site
Huntsville, Alabama
Vertex Investigational Site
Jackson, Tennessee
Vertex Investigational Site
Kalamazoo, Michigan
Vertex Investigational Site
Las Vegas, Nevada
Vertex Investigational Site
Long Beach, California
Vertex Investigational Site
Mesquite, Texas
Vertex Investigational Site
New Port Richey, Florida
Vertex Investigational Site
North Miami Beach, Florida
Vertex Investigational Site
Ocala, Florida
Vertex Investigational Site
Oklahoma City, Oklahoma
Vertex Investigational Site
Omaha, Nebraska
Vertex Investigational Site
San Antonio, Texas
Vertex Investigational Site
Springfield, Illinois
Vertex Investigational Site
St Louis, Missouri
Vertex Investigational Site
Tampa, Florida
Vertex Investigational Site
Tustin, California
Vertex Investigational Site
Wichita, Kansas
Poland10 sites
Vertex Investigational Site
Bialystok, 15-879
Vertex Investigational Site
Elblag, 82-300
Vertex Investigational Site
Krakow, 30-510
Vertex Investigational Site
Lublin, 20-607
Vertex Investigational Site
Poznan, 60-218
Vertex Investigational Site
Poznan, 60-539
Vertex Investigational Site
Torun, 87-100
Vertex Investigational Site
Warsaw, 00-029
Vertex Investigational Site
Warsaw, 02-118
Vertex Investigational Site
Warsaw, 04-141
Czechia6 sites
Vertex Investigational Site
Brno, 638 00
Vertex Investigational Site
Bruntál, 792 01
Vertex Investigational Site
Mladá Boleslav
Vertex Investigational Site
Ostrava - Trebovice
Vertex Investigational Site
Prague, 760 01
Vertex Investigational Site
Zlín, 760 01
Russia6 sites
Vertex Investigational Site
Kemerovo
Vertex Investigational Site
Moscow
Vertex Investigational Site
Ryazan
Vertex Investigational Site
Saint Petersburg, 190068
Vertex Investigational Site
Saint Petersburg, 191186
Vertex Investigational Site
Yaroslavl
Bulgaria5 sites
Vertex Investigational Site
Plovdiv, 4002
Vertex Investigational Site
Sevlievo
Vertex Investigational Site
Sofia, 1233
Vertex Investigational Site
Sofia, 1784
Vertex Investigational Site
Veliko Tarnovo, 5000
Ukraine5 sites
Vertex Investigational Site
Donetsk
Vertex Investigational Site
Kharkiv
Vertex Investigational Site
Lviv
Vertex Investigational Site
Odesa
Vertex Investigational Site
Vinnytsia
Argentina4 sites
Vertex Investigational Site
Buenos Aires, C1121ABE
Vertex Investigational Site
Buenos Aires, C1425EKG
Vertex Investigational Site
Buenos Aires, C1426AAL
Vertex Investigational Site
Santa Fe
Estonia4 sites
Vertex Investigational Site
Tallinn, 10117
Vertex Investigational Site
Tallinn, 10128
Vertex Investigational Site
Tallinn, 11312
Vertex Investigational Site
Tallinn, 13419
Germany4 sites
Vertex Investigational Site
Cologne, 50924
Vertex Investigational Site
Leipzig, 4103
Vertex Investigational Site
Würzburg, 97080
Vertex Investigational Site
Zerbst, 39261
Hungary4 sites
Vertex Investigational Site
Baja, 6500
Vertex Investigational Site
Budapest, 1023
Vertex Investigational Site
Budapest, 1036
Vertex Investigational Site
Szikszó, 3800
Mexico4 sites
Vertex Investigational Site
Chihuahua City
Vertex Investigational Site
Cuauhtémoc
Vertex Investigational Site
San Luis Potos
Vertex Investigational Site
San Miguel Chapultepec
Romania4 sites
Vertex Investigational Site
Brăila
Vertex Investigational Site
Bucharest, 010976
Vertex Investigational Site
Bucharest, 011198
Vertex Investigational Site
Judetul Galati
Slovakia4 sites
Vertex Investigational Site
Bratislava, 84104
Vertex Investigational Site
Dunajská Streda
Vertex Investigational Site
Poprad, 5801
Vertex Investigational Site
Rimavská Sobota, 97901
Serbia3 sites
Vertex Investigational Site
Belgrade, 11000
Vertex Investigational Site
Niška Banja, 18205
Vertex Investigational Site
Novi Sad, 21000
About this study
Official title: A 24-week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled, Phase 2 Study of Different Doses of VX-509 in Adult Subjects With Active Rheumatoid Arthritis on Stable Methotrexate Therapy With 104-Week Open Label Extension
This study is designed to evaluate the safety and efficacy of VX-509, an oral JAK3 inhibitor, for treatment of subjects with active RA who have had an inadequate response to Methotrexate.
Read the detailed description
VX-509 is an oral, selective Janus kinase 3 (JAK3) inhibitor being developed by Vertex. In autoimmune diseases, JAK3 is an essential component of the immune signaling cascade. This cascade ultimately contributes to abnormal immune response that results in chronic inflammation and, in the case of rheumatoid arthritis (RA), irreversible damage to cartilage and bones. Selective inhibition of JAK3 offers a new disease modifying approach to the treatment of RA, and a broad range of other autoimmune diseases.
- Conditions
- Rheumatoid Arthritis
- Being tested
- VX-509, VX-509 matching placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VX-509Drug
50 mg oral tablet
VX-509 matching placeboDrug
0 mg oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Placebo Arm | Placebo comparator | Not described Receives: Drug: VX-509 matching placebo |
| VX-509 100 mg qd Arm | Experimental | Not described Receives: Drug: VX-509 |
| VX-509 150 mg qd Arm | Experimental | Not described Receives: Drug: VX-509 |
| VX-509 100 mg bid Arm | Experimental | Not described Receives: Drug: VX-509 |
| VX-509 200 mg qd Arm | Experimental | Not described Receives: Drug: VX-509 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who achieve a 20% improvement in disease severity according to the American College of Rheumatology criteria, assessed using the C-reactive protein level (ACR20-CRP) response
Measured: Week 12
Change from baseline in Disease Activity Score 28 using C-reactive protein (DAS28- CRP)
Measured: Week 12
Safety and tolerability
Measured by incidence of treatment-emergent adverse events
Measured: Week 12
Safety and tolerability
Measured by clinical laboratory values (serum chemistry, hematology, coagulation studies, and urinalysis)
Measured: Week 12
Safety and tolerability
Measured by 12-lead ECG outcomes
Measured: Week 12
Safety and tolerability
Measured by vital signs
Measured: Week 12
Secondary outcomes (8)
Proportion of subjects who achieve an ACR20-CRP response
Measured: Week 24
Proportion of subjects who achieve ACR50-CRP and ACR70-CRP responses
Measured: Week 12 and 24
Proportion of subjects who achieve a moderate or good response according to the European League Against Rheumatism (EULAR) response criteria
Measured: Week 12 and 24
Proportion of subjects who achieve remission as defined by DAS28-CRP response
Measured: Week 12 and 24
Proportion of subjects who achieve remission as defined by the ACR/EULAR definition of remission
Measured: Week 12 and 24
Change from baseline in selected Patient Reported Outcomes (PROs)
Measured: Week 12 and 24
Change from baseline in DAS28- CRP
Measured: Week 24
Safety and tolerability as indicated by adverse events, hematology, clinical chemistry, coagulation, urinalysis, electrocardiograms (ECGs) and vital signs
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2012 (estimated)
- Study startApr 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Vertex Pharmaceuticals IncorporatedThe sponsor's other registered studies.
- 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
- 359 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ali Ashrafzadeh, MD, FACR, Study chair, Quintiles, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590459
- Sponsor's protocol ID
- VX11-509-102
- Other IDs
- 2011-004419-22
- Status last verified
- Oct 2015
- First submitted
- 27 Apr 2012
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled, Phase 2 Study of Different Doses of VX-509 in Adult Subjects With Active Rheumatoid Arthritis on Stable Methotrexate Therapy With 104-Week Open Label Extension
- ClinicalTrials.gov ID
- NCT01590459
- Acronym / sponsor ID
- VX11-509-102
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 359 participants (actual)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 3 May 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.
This study is designed to evaluate the safety and efficacy of VX-509, an oral JAK3 inhibitor, for treatment of subjects with active RA who have had an inadequate response to Methotrexate.
Detailed description
VX-509 is an oral, selective Janus kinase 3 (JAK3) inhibitor being developed by Vertex. In autoimmune diseases, JAK3 is an essential component of the immune signaling cascade. This cascade ultimately contributes to abnormal immune response that results in chronic inflammation and, in the case of rheumatoid arthritis (RA), irreversible damage to cartilage and bones. Selective inhibition of JAK3 offers a new disease modifying approach to the treatment of RA, and a broad range of other autoimmune diseases.
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 |
|---|---|---|
| Placebo Arm | Placebo comparator | Drug: VX-509 matching placebo |
| VX-509 100 mg qd Arm | Experimental | Drug: VX-509 |
| VX-509 150 mg qd Arm | Experimental | Drug: VX-509 |
| VX-509 100 mg bid Arm | Experimental | Drug: VX-509 |
| VX-509 200 mg qd Arm | Experimental | Drug: VX-509 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male and female subjects, between 18 and 80 years of age (inclusive)
- All subjects must have been diagnosed with RA
- Must have a swollen joint count of ≥6 out of 66 joints and tender joint count of ≥6 out of 68 joints
- Baseline CRP level must be above the upper limit of normal
- All subjects must have been receiving stable MTX coadministered with folic or folinic acid (at least 5 mg/week)
Key exclusion criteria (8 listed)
- History or presence of a clinically significant medical disorder other than RA that, in the opinion of the investigator and medical monitor, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
- Subjects with inflammatory, rheumatological disorders other than RA
- Pregnant or nursing female subjects
- Subjects who have a female partner who is pregnant, nursing, or planning to become pregnant
- Subjects who have planned major surgery (e.g., joint replacement) or procedures during the study
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 |
|---|---|---|
| VX-50950 mg oral tablet | Drug | VX-509 100 mg bid Arm, VX-509 100 mg qd Arm, VX-509 150 mg qd Arm, VX-509 200 mg qd Arm |
| VX-509 matching placebo0 mg oral tablet | Drug | Placebo Arm |
Primary outcome
Proportion of subjects who achieve a 20% improvement in disease severity according to the American College of Rheumatology criteria, assessed using the C-reactive protein level (ACR20-CRP) response
Time frame: Week 12
Change from baseline in Disease Activity Score 28 using C-reactive protein (DAS28- CRP)
Time frame: Week 12
Safety and tolerability
Time frame: Week 12
Measured by incidence of treatment-emergent adverse events
Safety and tolerability
Time frame: Week 12
Measured by clinical laboratory values (serum chemistry, hematology, coagulation studies, and urinalysis)
Safety and tolerability
Time frame: Week 12
Measured by 12-lead ECG outcomes
Safety and tolerability
Time frame: Week 12
Measured by vital signs
8 secondary outcomes
Proportion of subjects who achieve an ACR20-CRP response
Time frame: Week 24
Proportion of subjects who achieve ACR50-CRP and ACR70-CRP responses
Time frame: Week 12 and 24
Proportion of subjects who achieve a moderate or good response according to the European League Against Rheumatism (EULAR) response criteria
Time frame: Week 12 and 24
Proportion of subjects who achieve remission as defined by DAS28-CRP response
Time frame: Week 12 and 24
Proportion of subjects who achieve remission as defined by the ACR/EULAR definition of remission
Time frame: Week 12 and 24
Change from baseline in selected Patient Reported Outcomes (PROs)
Time frame: Week 12 and 24
Change from baseline in DAS28- CRP
Time frame: Week 24
Safety and tolerability as indicated by adverse events, hematology, clinical chemistry, coagulation, urinalysis, electrocardiograms (ECGs) and vital signs
Time frame: Week 24
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 20 Nov 2015.
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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.
Ali Ashrafzadeh, MD, FACR study chair
Quintiles, Inc.
94 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VX-509 in people with Rheumatoid Arthritis, run by Vertex Pharmaceuticals Incorporated at 94 sites in 14 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 11 inclusion and 8 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 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 94 sites in United States, Poland, Czechia, Russia, Bulgaria and 9 more countries. 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?
Proportion of subjects who achieve a 20% improvement in disease severity according to the American College of Rheumatology criteria, assessed using the C-reactive protein level (ACR20-CRP) response (time frame: Week 12). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2015.