NCT01830985

Brief Summary

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at below P25 for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Apr 2013

Geographic Reach
4 countries

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

November 20, 2015

Status Verified

October 1, 2015

Enrollment Period

1.2 years

First QC Date

April 10, 2013

Last Update Submit

October 23, 2015

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (4)

  • Long-term safety and tolerability of VX-509 treatment

    Measured by clinical laboratory tests

    Baseline through 104 weeks

  • Long-term safety and tolerability of VX-509 treatment

    Measured by adverse events (AEs)

    Baseline through 104 weeks

  • Long-term safety and tolerability of VX-509 treatment

    Measured by electrocardiograms (ECGs)

    Baseline through 104 weeks

  • Long-term safety and tolerability of VX-509 treatment

    Measured by vital signs

    Baseline through 104 weeks

Secondary Outcomes (12)

  • Proportion of subjects who achieve CDAI LDA (≤10) or CDAI remission (≤2.8)

    Baseline through 104 weeks

  • Proportion of subjects who achieve ≥20% (50%, 70%) improvement in disease severity according to the ACR criteria, using CRP (ACR20 CRP, ACR50 CRP, ACR70 CRP)

    Baseline through 104 weeks

  • Change from baseline in DAS28 using CRP (4-component) (DAS28 4[CRP])

    Baseline through 104 weeks

  • Proportion of subjects with DAS28 4(CRP) <2.6 (DAS remission)

    Baseline through 104 weeks

  • Proportion of subjects who achieve a moderate, good, or no response according to the EULAR response criteria from baseline

    Baseline through 104 weeks

  • +7 more secondary outcomes

Other Outcomes (1)

  • Change in Outcome Measures in Rheumatology Clinical Trials (OMERACT) RAMRIS synovitis score, bone marrow edema (osteitis), erosion score, and joint space narrowing score by magnetic resonance imaging (MRI) in the designated hand

    Baseline through week 12

Study Arms (1)

Single Arm VX-509

EXPERIMENTAL
Drug: VX-509

Interventions

VX-509DRUG

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)

Single Arm VX-509

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Vertex Investigational Site

Upland, California, United States

Location

Vertex Investigational Site

Fort Lauderdale, Florida, United States

Location

Vertex Investigational Site

Venice, Florida, United States

Location

Vertex Investigational Site

West Palm Beach, Florida, United States

Location

Vertex Investigational Site

Canton, Georgia, United States

Location

Vertex Investigational Site

Decatur, Georgia, United States

Location

Vertex Investigational Site

Elizabethtown, Kentucky, United States

Location

Vertex Investigational Site

Fredrick, Maryland, United States

Location

Vertex Investigational Site

Lincoln, Nebraska, United States

Location

Vertex Investigational Site

Rochester, New York, United States

Location

Vertex Investigational Site

Greensboro, North Carolina, United States

Location

Vertex Investigational Site

Duncansville, Pennsylvania, United States

Location

Vertex Investigational Site

Charleston, South Carolina, United States

Location

Vertex Investigational Site

Memphis, Tennessee, United States

Location

Vertex Investigational Site

Katy, Texas, United States

Location

Vertex Investigational Site

San Antonio, Texas, United States

Location

Vertex Investigational Site

Webster, Texas, United States

Location

Vertex Investigational Site

Spokane, Washington, United States

Location

Vertex Investigational Site

Tallinn, Estonia

Location

Vertex Investigational Site

Vilnius, Lithuania

Location

Vertex Investigational Site

Pretoria, South Africa

Location

Vertex Investigational Site

Stellenbosch, South Africa

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

2-((2-(1H-pyrrolo(2,3-b)pyridin-3-yl)pyrimidin-4-yl)amino)-2-methyl-N-(2,2,2-trifluoroethyl)butanamide

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Bradley Bloom, MD, FACR, FAAP

    Vertex Pharmaceuticals Incorporated

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2013

First Posted

April 12, 2013

Study Start

April 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

November 20, 2015

Record last verified: 2015-10

Locations

LI(1)US(18)ZA(2)ES(1)