A 12-week Study of 4 Doses of VX-509 in Subjects With Active Rheumatoid Arthritis

December 12, 2012 updated by: Vertex Pharmaceuticals Incorporated

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
206

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium
  • Croatia
      • Karlovac, Croatia
      • Opatija, Croatia
      • Zagreb, Croatia
  • Germany
      • Erfurt, Germany
      • Frankfurt, Germany
      • Hamburg, Germany
      • Hildesheim, Germany
      • Nauheim, Germany
      • Zerbst, Germany
  • Hungary
      • Balatonfured, Hungary
      • Budapest, Hungary
      • Debrecen, Hungary
      • Veszprem, Hungary
  • Poland
      • Elblag, Poland
      • Limanow, Poland
      • Lublin, Poland
      • Wroclaw, Poland
  • Puerto Rico
      • San Juan, Puerto Rico
  • Romania
      • Baia Mare, Romania
      • Braila, Romania
      • Bucharest, Romania
      • Galati, Romania
  • Russian Federation
      • Kemerovo, Russian Federation
      • Novosibirsk, Russian Federation
      • Ryazan, Russian Federation
      • Vladimir, Russian Federation
      • Voronezh, Russian Federation
  • Serbia
      • Belgrade, Serbia
      • Niska Banja, Serbia
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
      • Huntsville, Alabama, United States, 35801
    • Arizona
      • Peoria, Arizona, United States, 85381
    • California
      • La Mesa, California, United States, 97942
    • Connecticut
      • Trumbull, Connecticut, United States, 06611
    • Florida
      • Tampa, Florida, United States, 33612
      • Tampa, Florida, United States, 33614
      • Venice, Florida, United States, 34292
    • Georgia
      • Decatur, Georgia, United States, 30033
    • Massachusetts
      • Worcester, Massachusetts, United States, 01610
    • Missouri
      • St. Louis, Missouri, United States, 63141
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
    • South Carolina
      • Charleston, South Carolina, United States, 29406
    • Texas
      • Dallas, Texas, United States, 75235
    • Washington
      • Spokane, Washington, United States, 99204
    • West Virginia
      • Clarksburg, West Virginia, United States, 26301

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
tablet, placebo b.i.d. for 12 weeks
Experimental: 25 mg b.i.d. VX-509
Drug: VX-509
tablets, 25mg b.i.d. for 12 weeks
Drug: VX-509
tablet, 50 mg b.i.d. for 12 weeks
Drug: VX-509
tablet, 100 mg b.i.d. for 12 weeks
Drug: VX-509
tablet, 150 mg b.i.d. for 12 weeks
Experimental: 50 mg b.i.d. VX-509
Drug: VX-509
tablets, 25mg b.i.d. for 12 weeks
Drug: VX-509
tablet, 50 mg b.i.d. for 12 weeks
Drug: VX-509
tablet, 100 mg b.i.d. for 12 weeks
Drug: VX-509
tablet, 150 mg b.i.d. for 12 weeks
Experimental: 100 mg b.i.d. VX-509
Drug: VX-509
tablets, 25mg b.i.d. for 12 weeks
Drug: VX-509
tablet, 50 mg b.i.d. for 12 weeks
Drug: VX-509
tablet, 100 mg b.i.d. for 12 weeks
Drug: VX-509
tablet, 150 mg b.i.d. for 12 weeks
Experimental: 150 mg b.i.d. VX-509
Drug: VX-509
tablets, 25mg b.i.d. for 12 weeks
Drug: VX-509
tablet, 50 mg b.i.d. for 12 weeks
Drug: VX-509
tablet, 100 mg b.i.d. for 12 weeks
Drug: VX-509
tablet, 150 mg b.i.d. for 12 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Proportion of subjects who achieve an ACR20 response
Time Frame: Week 12
Week 12
Change from baseline in DAS28
Time Frame: Week 12
Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Proportion of subjects who achieve an ACR50,70 response
Time Frame: Week 12
Week 12
Proportion of subjects who achieve moderate or good EULAR response
Time Frame: Week 12
Week 12
Magnitude of improvement in the components of the ACR response criteria
Time Frame: Week 12
Week 12
Pharmacokinetics of VX-509
Time Frame: Week 6
Week 6
Pharmacodynamics (PD) of biomarker responses
Time Frame: Week 6
Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vertex Pharmaceuticals Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VX09-509-101
  • 2009-017438-32 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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