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A Phase 2/3 Open-label Extension Study to Evaluate Long-Term Safety and Efficacy With VX-509 in Subjects With Rheumatoid Arthritis

NCT ID: NCT01830985

Last Updated: 2015-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-07-31

Brief Summary

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This study is designed to evaluate the long-term safety and tolerability of VX-509 in subjects with active rheumatoid arthritis (RA) on DMARD therapy. This study will enroll subjects who completed a previous designated study with VX-509 (e.g., Study VX12-509-103).

Detailed Description

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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.

This study will follow a "treat to target" (T2T) paradigm. T2T strategies have been followed in non-rheumatologic fields for decades. T2T trials have been conducted for RA from the late 1990's, and have substantiated the concept that treating to a target is associated with a better outcome than standard of care treatment. This has led to recommendations by experts to use T2T strategies in clinical practice.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm VX-509

Group Type EXPERIMENTAL

VX-509

Intervention Type DRUG

VX-509 dose may be increased every 8 weeks in a stepwise fashion from 100 to 150 mg and from 150 to 200 mg, as needed (determined by ongoing disease activity by CDAI)

Interventions

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VX-509

VX-509 dose may be increased every 8 weeks in a stepwise fashion from 100 to 150 mg and from 150 to 200 mg, as needed (determined by ongoing disease activity by CDAI)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects must have completed the assigned study drug treatment phase of a previous VX-509 study (e.g., Study 103).
* Subjects must voluntarily sign and date the Study 104 informed consent document.
* Subject must be willing and able to comply with the scheduled visits, treatment plan, laboratory tests, contraceptive guidelines, and other study procedures.

Exclusion Criteria

* Inflammatory and rheumatological disorders other than RA, where arthritis may be a prominent feature.
* History of any clinically significant illness that might, in the opinion of the investigator, confound the results of the study or pose an additional risk in administering study drug(s) to the subject
* History of tuberculosis (TB), regardless of history of antimycobacterial treatment.
* Planned surgery during the study.
* History of alcohol or drug abuse, or excessive alcohol consumption as determined by the investigator, during the previous 12 months before Day 1.
* Pregnant or nursing an infant or with a life partner who is pregnant, nursing, or planning to become pregnant
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bradley Bloom, MD, FACR, FAAP

Role: STUDY_CHAIR

Vertex Pharmaceuticals Incorporated

Locations

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Vertex Investigational Site

Upland, California, United States

Site Status

Vertex Investigational Site

Fort Lauderdale, Florida, United States

Site Status

Vertex Investigational Site

Venice, Florida, United States

Site Status

Vertex Investigational Site

West Palm Beach, Florida, United States

Site Status

Vertex Investigational Site

Canton, Georgia, United States

Site Status

Vertex Investigational Site

Decatur, Georgia, United States

Site Status

Vertex Investigational Site

Elizabethtown, Kentucky, United States

Site Status

Vertex Investigational Site

Fredrick, Maryland, United States

Site Status

Vertex Investigational Site

Lincoln, Nebraska, United States

Site Status

Vertex Investigational Site

Rochester, New York, United States

Site Status

Vertex Investigational Site

Greensboro, North Carolina, United States

Site Status

Vertex Investigational Site

Duncansville, Pennsylvania, United States

Site Status

Vertex Investigational Site

Charleston, South Carolina, United States

Site Status

Vertex Investigational Site

Memphis, Tennessee, United States

Site Status

Vertex Investigational Site

Katy, Texas, United States

Site Status

Vertex Investigational Site

San Antonio, Texas, United States

Site Status

Vertex Investigational Site

Webster, Texas, United States

Site Status

Vertex Investigational Site

Spokane, Washington, United States

Site Status

Vertex Investigational Site

Tallinn, , Estonia

Site Status

Vertex Investigational Site

Vilnius, , Lithuania

Site Status

Vertex Investigational Site

Pretoria, , South Africa

Site Status

Vertex Investigational Site

Stellenbosch, , South Africa

Site Status

Countries

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United States Estonia Lithuania South Africa

Other Identifiers

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2012-004342-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VX12-509-104

Identifier Type: -

Identifier Source: org_study_id