Rheumatoid ArthritisPhase 2NCT01052194
A 12-week Study of 4 Doses of VX-509 in Subjects With Active Rheumatoid Arthritis
A Phase 2 study testing VX-509 in people with Rheumatoid Arthritis, run by Vertex Pharmaceuticals Incorporated at 48 sites in 10 countries.
Trial summary
This study is designed to evaluate safety and assess initial efficacy of VX-509, a JAK3 inhibitor, for treatment of subjects with active RA. This study will assess the clinical response of 4 doses of VX-509 compared to placebo when administered for 12 weeks to patients with active RA. Read more about this study
- Who is it for?
- Ages 18 to 75 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
- 206 participants
- Where
- 48 sitesin 10 countries
- Study dates
- Feb 2010to Jul 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects must have been diagnosed with RA as defined by the ACR revised criteria with disease duration of at least 6 months from confirmed diagnosis
- Subjects must have a swollen joint count of ≥6 out of 28 joints and tender joint count of ≥6 out of 28 joints. Joints that have had prior surgery are to be excluded from the joint count.
- Baseline CRP level must be 1.5 times greater than the upper limit of normal at Screening.
- Subjects must have failed at least 1 nonbiologic DMARD for any reason.
- Subjects may have previously failed no more than 1 biologic DMARD and discontinued treatment for reasons other than inadequate response. Subjects must not have been treated with Rituximab previously.
- Subjects must be willing to comply with contraception requirements.
Who cannot join
- Subjects with inflammatory rheumatological disorders other than RA.
- History or evidence of a clinically significant disorder other than RA (including but not limited to cardiopulmonary, oncologic, renal, metabolic, hematologic or psychiatric disorders), condition or disease 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 clinically important abnormalities in screening physical examination or in screening laboratory test results (including the presence of either hepatitis B surface antigen, hepatitis C virus antibody, or HIV types 1 -- Subjects with elevation in alanine aminotransferase or aspartate aminotransferase above the upper limit of normal.
- History of hematologic disorders including neutropenia and thrombocytopenia.
- Subjects with an acute or chronic active infection requiring systemic antimicrobial treatment, or subjects who are at high risk of developing an infection due to a compromised immune system. Antifungals for onychomycosis or low-dose antibiotics for rosacea, that are not inhibitors or inducers of CYP3A, will be allowed.
- Subjects who require concomitant use of any inhibitors or inducers of cytochrome P450 (CYP) 3A.
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- Subjects who have been treated with intra-articular injections of corticosteroids within 28 days prior to Day 1.
- Subjects who have planned major surgery (e.g., joint replacement) or any procedures during the study.
- Have received any live, attenuated vaccinations within 1 month prior to study drug administration.
- History of drug or alcohol abuse or excessive alcohol as determined by the investigator, during the last 12 months before the screening visit.
- History of TB infection of any kind (pulmonary or extrapulmonary, active or latent), regardless of history of anti-TB treatment.
Trial locations and contacts
48 sites in 10 countries.
48 sites in 10 countries
United States18 sites
Study site
Birmingham, Alabama, 35216
Study site
Charleston, South Carolina, 29406
Study site
Charlotte, North Carolina, 28210
Study site
Clarksburg, West Virginia, 26301
Study site
Dallas, Texas, 75235
Study site
Decatur, Georgia, 30033
Study site
Duncansville, Pennsylvania, 16635
Study site
Huntsville, Alabama, 35801
Study site
La Mesa, California, 97942
Study site
Oklahoma City, Oklahoma, 73104
Study site
Peoria, Arizona, 85381
Study site
Spokane, Washington, 99204
Study site
St Louis, Missouri, 63141
Study site
Tampa, Florida, 33612
Study site
Tampa, Florida, 33614
Study site
Trumbull, Connecticut, 06611
Study site
Venice, Florida, 34292
Study site
Worcester, Massachusetts, 01610
Germany6 sites
Study site
Erfurt
Study site
Frankfurt
Study site
Hamburg
Study site
Hildesheim
Study site
Nauheim
Study site
Zerbst
Russia5 sites
Study site
Kemerovo
Study site
Novosibirsk
Study site
Ryazan
Study site
Vladimir
Study site
Voronezh
Hungary4 sites
Study site
Balatonfüred
Study site
Budapest
Study site
Debrecen
Study site
Veszprém
Poland4 sites
Study site
Elblag
Study site
Limanow
Study site
Lublin
Study site
Wroclaw
Romania4 sites
Study site
Baia Mare
Study site
Brăila
Study site
Bucharest
Study site
Galati
About this study
Official title: A 12-week, Double-blind, Randomized, Parallel-group, Placebo-controlled Study of 4 Doses of VX-509 in Subjects With Active Rheumatoid Arthritis
This study is designed to evaluate safety and assess initial efficacy of VX-509, a JAK3 inhibitor, for treatment of subjects with active RA. This study will assess the clinical response of 4 doses of VX-509 compared to placebo when administered for 12 weeks to patients with active RA. The study will also evaluate the safety and tolerability of VX-509 compared to placebo when administered for 12 weeks to subjects with active RA.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Placebo, VX-509
- Keywords
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
tablet, placebo b.i.d. for 12 weeks
VX-509Drug
tablets, 25mg b.i.d. for 12 weeks
VX-509Drug
tablet, 50 mg b.i.d. for 12 weeks
VX-509Drug
tablet, 100 mg b.i.d. for 12 weeks
VX-509Drug
tablet, 150 mg b.i.d. for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 25 mg b.i.d. VX-509 | Experimental | Not described Receives: Drug: VX-509 |
| 50 mg b.i.d. VX-509 | Experimental | Not described Receives: Drug: VX-509 |
| 100 mg b.i.d. VX-509 | Experimental | Not described Receives: Drug: VX-509 |
| 150 mg b.i.d. VX-509 | Experimental | Not described Receives: Drug: VX-509 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who achieve an ACR20 response
Measured: Week 12
Change from baseline in DAS28
Measured: Week 12
Secondary outcomes (5)
Proportion of subjects who achieve an ACR50,70 response
Measured: Week 12
Proportion of subjects who achieve moderate or good EULAR response
Measured: Week 12
Magnitude of improvement in the components of the ACR response criteria
Measured: Week 12
Pharmacokinetics of VX-509
Measured: Week 6
Pharmacodynamics (PD) of biomarker responses
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionJul 2011
- Study completionJul 2011
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Vertex Pharmaceuticals Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01052194
- Sponsor's protocol ID
- VX09-509-101
- Other IDs
- 2009-017438-32, 2009
- Status last verified
- Dec 2012
- First submitted
- 18 Jan 2010
- Last updated
- 13 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week, Double-blind, Randomized, Parallel-group, Placebo-controlled Study of 4 Doses of VX-509 in Subjects With Active Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01052194
- Acronym / sponsor ID
- VX09-509-101
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 20 Jan 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.
This study is designed to evaluate safety and assess initial efficacy of VX-509, a JAK3 inhibitor, for treatment of subjects with active RA. This study will assess the clinical response of 4 doses of VX-509 compared to placebo when administered for 12 weeks to patients with active RA. The study will also evaluate the safety and tolerability of VX-509 compared to placebo when administered for 12 weeks to subjects with active RA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 25 mg b.i.d. VX-509 | Experimental | Drug: VX-509 |
| 50 mg b.i.d. VX-509 | Experimental | Drug: VX-509 |
| 100 mg b.i.d. VX-509 | Experimental | Drug: VX-509 |
| 150 mg b.i.d. VX-509 | Experimental | Drug: VX-509 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All subjects must have been diagnosed with RA as defined by the ACR revised criteria with disease duration of at least 6 months from confirmed diagnosis
- Subjects must have a swollen joint count of ≥6 out of 28 joints and tender joint count of ≥6 out of 28 joints. Joints that have had prior surgery are to be excluded from the joint count.
- Baseline CRP level must be 1.5 times greater than the upper limit of normal at Screening.
- Subjects must have failed at least 1 nonbiologic DMARD for any reason.
- Subjects may have previously failed no more than 1 biologic DMARD and discontinued treatment for reasons other than inadequate response. Subjects must not have been treated with Rituximab previously.
Key exclusion criteria (11 listed)
- Subjects with inflammatory rheumatological disorders other than RA.
- History or evidence of a clinically significant disorder other than RA (including but not limited to cardiopulmonary, oncologic, renal, metabolic, hematologic or psychiatric disorders), condition or disease 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 clinically important abnormalities in screening physical examination or in screening laboratory test results (including the presence of either hepatitis B surface antigen, hepatitis C virus antibody, or HIV types 1 -- Subjects with elevation in alanine aminotransferase or aspartate aminotransferase above the upper limit of normal.
- History of hematologic disorders including neutropenia and thrombocytopenia.
- Subjects with an acute or chronic active infection requiring systemic antimicrobial treatment, or subjects who are at high risk of developing an infection due to a compromised immune system. Antifungals for onychomycosis or low-dose antibiotics for rosacea, that are not inhibitors or inducers of CYP3A, will be allowed.
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 |
|---|---|---|
| Placebotablet, placebo b.i.d. for 12 weeks | Drug | Placebo |
| VX-509tablets, 25mg b.i.d. for 12 weeks | Drug | 25 mg b.i.d. VX-509 |
| VX-509tablet, 50 mg b.i.d. for 12 weeks | Drug | 50 mg b.i.d. VX-509 |
| VX-509tablet, 100 mg b.i.d. for 12 weeks | Drug | 100 mg b.i.d. VX-509 |
| VX-509tablet, 150 mg b.i.d. for 12 weeks | Drug | 150 mg b.i.d. VX-509 |
Primary outcome
Proportion of subjects who achieve an ACR20 response
Time frame: Week 12
Change from baseline in DAS28
Time frame: Week 12
5 secondary outcomes
Proportion of subjects who achieve an ACR50,70 response
Time frame: Week 12
Proportion of subjects who achieve moderate or good EULAR response
Time frame: Week 12
Magnitude of improvement in the components of the ACR response criteria
Time frame: Week 12
Pharmacokinetics of VX-509
Time frame: Week 6
Pharmacodynamics (PD) of biomarker responses
Time frame: Week 6
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 13 Dec 2012.
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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.
Medical Monitor study director
Vertex Pharmaceuticals Incorporated
48 sites in 10 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 48 sites in 10 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 6 inclusion and 11 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 13 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Germany, Russia, Hungary, Poland and 5 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 an ACR20 response (time frame: Week 12). The study lists 2 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 13 Dec 2012.