Rheumatoid Arthritis MedDRA version: 16.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: VX-509
Product Code: VX-509
Pharmaceutical Form: Tablet
INN or Proposed INN: VX-509
Current Sponsor code: VX-509
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrati
Sponsors
Vertex Pharmaceuticals Incorporated
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subjects must have completed the assigned study drug treatment phase of a previous VX 509 study (e.g., Study 103). 2.Subjects must voluntarily sign and date the Study 104 informed consent document. 3.Subject must be willing and able to comply with the scheduled visits, treatment plan, laboratory tests, contraceptive guidelines, and other study procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1.Inflammatory and rheumatological disorders other than RA, where arthritis may be a prominent feature 2.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. 3.History of cancer, except squamous or basal cell cancers of the skin or in situ cancer of the cervix. 4.History of hematologic disorders including neutropenia and thrombocytopenia other than Felty syndrome. 5.History of tuberculosis (TB), regardless of history of antimycobacterial treatment. 6.Acute or chronic active infection requiring systemic antimicrobial treatment with the exception of onychomycosis receiving antifungal medication or acne and rosacea receiving low-dose antibiotics. 7.History of previous osteomyelitis, infected joint, or joint prosthesis. 8.Subjects who are at high risk of developing an infection due to a compromised immune system including poorly controlled diabetes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety and tolerability of VX-509 treatment in subjects with RA on DMARD therapy;Primary end point(s): Long-term safety and tolerability of VX-509 treatment, as determined by adverse events (AEs), clinical laboratory tests, electrocardiograms (ECGs), and vital signs;Timepoint(s) of evaluation of this end point: Week 104;Secondary Objective: •To evaluate the efficacy of long-term VX-509 treatment in subjects with RA on DMARD therapy in a T2T paradigm, including induction of remission, LDA, major arthritis improvement, physical functioning, and ability to taper concurrent DMARD and corticosteroid (if receiving) •To evaluate arthritis improvement with initial VX 509 treatment in subjects with RA on DMARD therapy who previously received no VX-509 treatment (placebo subjects) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Proportion of subjects who achieve CDAI LDA (=10) or CDAI remission (=2.8) from baseline over time •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) response from baseline over time •Change from baseline in DAS28 using CRP (4-component) (DAS28 4[CRP]) over time •Proportion of subjects with DAS28 4(CRP) <2.6 (DAS remission) from baseline over time •Proportion of subjects who achieve a moderate, good, or no response according to the EULAR response criteria from baseline over time •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) •ACR hybrid scores from baseline over time •Proportion of subjects who achieve ACR20/50/70 with erythrocyte sedimentation rate (ESR) and DAS28-4(ESR) response from baseline over time •Proportion of subjects with DAS28 4(CRP) <3.2 (DAS LDA) from baseline over time •Proportion of subjects achieving a clinical remission (2011 ACR/EULAR criteria), including subsets achieving either the low joint count or SDAI remission options (or both) from baseline over time •Change from baseline in Health Assessment Questionnaire – Disability Index (HAQ DI) over time •Change from baseline in health-related quality of life assessed by 36-Item Short Form [SF-36]) Physical Component Summary (PCS) score and Physical Function (PF) subscale over time ;Timepoint(s) of evaluation of this end point: Week 104 | — |
Countries
Denmark, Estonia, Lithuania, Netherlands, South Africa, United States
Contacts
Public ContactClinical Trials and Medical Info
Vertex Pharmaceuticals Incorporated
Outcome results
None listed