Rheumatoid Arthritis MedDRA version: 16.0 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
Current Sponsor code: VX-509
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutica
Sponsors
Vertex Pharmaceuticals Incorporated
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects, between 18 and 80 years of age (inclusive) 2. All subjects must have been diagnosed with RA 3. Must have a swollen joint count of =6 out of 66 joints and tender joint count of =6 out of 68 joints 4. Baseline CRP level must be above the upper limit of normal 5. All subjects must have been receiving stable MTX coadministered with folic or folinic acid (at least 5 mg/week) 6. Subjects may remain on 1 nonsteroidal anti-inflammatory medication during the study (aspirin = 325 mg/day is allowed). 7. Subjects must not have received prior treatment with a JAK inhibitor 8. Subjects who are on an additional nonbiologic DMARD (e.g., sulfasalazine) must be willing to discontinue that DMARD after signing consent, except for hydroxcychloroquine 9. Subjects may have received previous therapy with a single TNF inhibitor (e.g., etanercept, adalimumab, infliximab, golimumab, certolizumab pegol) 10. Females must have a negative pregnancy test prior to study dosing 11. Sexually active subjects and their partners must agree to contraceptive requirements 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 280 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: 1. History or presence of a clinically significant medical disorder other than RA 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. 2. Subjects with inflammatory, rheumatological disorders other than RA 3. Pregnant or nursing female subjects 4. Subjects who have a female partner who is pregnant, nursing, or planning to become pregnant 5. Subjects who have planned major surgery (e.g., joint replacement) or procedures during the study 6. History of drug abuse or positive drug screen 7. History of alcohol abuse or excessive alcohol consumption 8. History of tuberculosis (TB) infection of any kind (pulmonary or extrapulmonary, active or latent), regardless of history of anti-TB treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of multiple doses of VX-509 when administered for 12 weeks in subjects with active RA on stable MTX therapy. To evaluate the safety and tolerability of multiple doses of VX-509 when administered for 12 weeks in subjects with active RA on stable MTX therapy.;Secondary Objective: To evaluate the efficacy of multiple doses of VX-509 when administered for 24 weeks To evaluate the safety and tolerability of multiple doses of VX-509 when administered for 24 weeks To investigate the PK of VX-509 after multiple doses of VX-509 are administered To investigate the effect of VX-509 on the PK of MTX, after multiple doses of VX-509 are administered To determine the pharmacodynamic relationships between the exposure of VX-509, MTX, and biomarker responses To evaluate the durability of efficacy during the OLE To determine whether subjects who receive their first dose or a higher dose of VX-509 during the OLE attain or increase their level of efficacy To evaluate the safety and tolerability of chronic administration of VX-509 during the OLE;Primary end point(s): Proportion of subjects who achieve a 20% improvement in disease severity according to the American College of Rheumatology criteria, assessed using the C-reactive protein level (ACR20-CRP) response [Time Frame: Week 12] Change from baseline in Disease Activity Score 28 using C-reactive protein calculated using the formula with 4 variables (DAS28-4 CRP) Safety and tolerability as indicated by adverse events, hematology, clinical chemistry, coagulation, urinalysis, electrocardiograms (ECGs) and vital signs [Time Frame: Week 12] ;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The primary outcome measures at 24 weeks Proportion of subjects who achieve ACR50-CRP and ACR70-CRP responses [Time Frame: Week 12 and 24] Proportion of subjects who achieve a moderate or good response according to the European League Against Rheumatism (EULAR) response criteria [Time Frame: Week 12 and 24] Proportion of subjects who achieve remission as defined by DAS28-4 (CRP) response [Time Frame: Week 12 and 24] Proportion of subjects who achieve remission as defined by the ACR/EULAR definition of remission [Time Frame: Week 12 and 24] Change from baseline in selected Patient Reported Outcomes (PROs) [Time Frame: Week 12 and 24] ;Timepoint(s) of evaluation of this end point: Week 12 and 24 | — |
Countries
Argentina, Bulgaria, Czech Republic, Estonia, Germany, Hungary, Mexico, Peru, Poland, Romania, Russian Federation, Serbia, Slovakia, Ukraine, United States
Contacts
Public ContactClinical Trials and Medical Info
Vertex Pharmaceuticals Incorporated
Outcome results
None listed