Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004342-14 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm VX-509 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bradley Bloom, MD, FACR, FAAP | Vertex Pharmaceuticals Incorporated | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vertex Investigational Site | Upland | California | United States | |||
| Vertex Investigational Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| 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) | Baseline through 104 weeks |
| ACR hybrid scores | Baseline through 104 weeks |
| Proportion of subjects who achieve ACR20/50/70 with erythrocyte sedimentation rate (ESR) and DAS28 4(ESR) response from baseline | Baseline through 104 weeks |
| Proportion of subjects with DAS28 4(CRP) <3.2 (DAS LDA) from baseline | Baseline through 104 weeks |
| 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 | Baseline through week 104 |
| Change from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) | Baseline through 104 weeks |
| 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 | Baseline through 104 weeks |
| Fort Lauderdale |
| Florida |
| United States |
| Vertex Investigational Site | Venice | Florida | United States |
| Vertex Investigational Site | West Palm Beach | Florida | United States |
| Vertex Investigational Site | Canton | Georgia | United States |
| Vertex Investigational Site | Decatur | Georgia | United States |
| Vertex Investigational Site | Elizabethtown | Kentucky | United States |
| Vertex Investigational Site | Fredrick | Maryland | United States |
| Vertex Investigational Site | Lincoln | Nebraska | United States |
| Vertex Investigational Site | Rochester | New York | United States |
| Vertex Investigational Site | Greensboro | North Carolina | United States |
| Vertex Investigational Site | Duncansville | Pennsylvania | United States |
| Vertex Investigational Site | Charleston | South Carolina | United States |
| Vertex Investigational Site | Memphis | Tennessee | United States |
| Vertex Investigational Site | Katy | Texas | United States |
| Vertex Investigational Site | San Antonio | Texas | United States |
| Vertex Investigational Site | Webster | Texas | United States |
| Vertex Investigational Site | Spokane | Washington | United States |
| Vertex Investigational Site | Tallinn | Estonia |
| Vertex Investigational Site | Vilnius | Lithuania |
| Vertex Investigational Site | Pretoria | South Africa |
| Vertex Investigational Site | Stellenbosch | South Africa |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000596981 | 2-((2-(1H-pyrrolo(2,3-b)pyridin-3-yl)pyrimidin-4-yl)amino)-2-methyl-N-(2,2,2-trifluoroethyl)butanamide |
Not provided
Not provided
Not provided