Skip to main content
OpenTrials
Completed

NCT Number: NCT01830985

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Vertex Investigational Site, Tallinn, Estonia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VX-509

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)

Primary outcomes

  1. Long-term safety and tolerability of VX-509 treatment

    Time frame: Baseline through 104 weeks

    Measured by clinical laboratory tests

  2. Long-term safety and tolerability of VX-509 treatment

    Time frame: Baseline through 104 weeks

    Measured by adverse events (AEs)

  3. Long-term safety and tolerability of VX-509 treatment

    Time frame: Baseline through 104 weeks

    Measured by electrocardiograms (ECGs)

  4. Long-term safety and tolerability of VX-509 treatment

    Time frame: Baseline through 104 weeks

    Measured by vital signs

Secondary outcomes

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

    Time frame: Baseline through 104 weeks

  2. 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)

    Time frame: Baseline through 104 weeks

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

    Time frame: Baseline through 104 weeks

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

    Time frame: Baseline through 104 weeks

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

    Time frame: Baseline through 104 weeks

  6. Percentage of subjects with decreased dose of DMARD and/or corticosteroid (if receiving), including the subsets with 50% withdrawal and with full withdrawal (dose = 0)

    Time frame: Baseline through 104 weeks

  7. ACR hybrid scores

    Time frame: Baseline through 104 weeks

  8. Proportion of subjects who achieve ACR20/50/70 with erythrocyte sedimentation rate (ESR) and DAS28 4(ESR) response from baseline

    Time frame: Baseline through 104 weeks

  9. Proportion of subjects with DAS28 4(CRP) <3.2 (DAS LDA) from baseline

    Time frame: Baseline through 104 weeks

  10. Proportion of subjects achieving a clinical remission (2011 ACR/EULAR criteria), including subsets achieving either the low joint count or simplified disease activity index (SDAI) score remission options (or both) from baseline

    Time frame: Baseline through week 104

  11. Change from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)

    Time frame: Baseline through 104 weeks

  12. Change from baseline in health-related quality of life assessed by 36-Item Short Form (SF 36) Physical Component Summary score and Physical Function (PF) subscale

    Time frame: Baseline through 104 weeks

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

    Time frame: Baseline through week 12

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study title

A Phase 2/3 Open-label Extension Study to Evaluate Long-Term Safety and Efficacy With VX-509 in a Treat to Target Setting in Subjects With Rheumatoid Arthritis on Disease-Modifying Antirheumatic Drugs

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 12, 2013
Registry last updated
Nov 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.