Phase 3
Completed N=253
A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Combination Therapy of T-614 and Methotrexate in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate
Source: ClinicalTrials.gov NCT00965757 ↗Enrolled (actual)
253
Serious AEs
1.3%
Results posted
Jun 2015
Primary outcomePrimary: Percentage of American College of Rheumatology [ACR] 20 Criteria Responders — 69.5; 30.7; NA; 71.3 Percentage of Participants
Summary
The purpose of this study is to evaluate the efficacy and safety of T-614 versus placebo when added to ongoing, stable-dose methotrexate therapy in patients with persistently active rheumatoid arthritis
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of American College of Rheumatology [ACR] 20 Criteria Responders |
69.5; 30.7; NA; 71.3; NA; 72.1 | — |
| SECONDARY Change From Baseline in Tender Joint Counts and Swollen Joint Counts |
12.5; 13.3; 13.8; -7.4; -4.6; NA | — |
| SECONDARY Change From Baseline in PAP, PtGADA and PyGADA |
47.5; 46.4; 44.8; -22; -2.5; NA | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) |
0.8178; 0.7344; 0.7188; -0.3544; 0.0256; NA | — |
| SECONDARY Change From Baseline in C-reactive Protein (CRP) |
1.843; 1.705; 1.714; -0.528; 0.47; NA | — |
| SECONDARY Change From Baseline in Erythrocyte Sedimentation Rate (ESR) |
45.6; 41.8; 40.1; -9.3; 2.6; NA | — |
| SECONDARY Disease Activity Score in 28 Joints (DAS28): The Rates of Remission (DAS28-CRP Less Than 2.6), and Low Disease Activity (DAS28-CRP Less Than 3.2) |
45; 8; NA; 56; NA; 23 | — |
| SECONDARY Percentage of ACR 50 Criteria Responders |
38.4; 15.9; NA; 49.4; NA; 45.6 | — |
| SECONDARY Percentage of ACR 70 Criteria Responders |
17.1; 5.7; NA; 23.8; NA; 22.1 | — |
Eligibility Criteria
Inclusion criteria
- Subjects who have a diagnosis of Rheumatoid Arthritis by the ACR criteria
- Age greater or 20 years and less than 70 years old
Exclusion criteria
- Subject who is considered by the investigator, for any reason, to be an unsuitable candidate for the study
- Women of childbearing potential who are not practicing a successful method of contraception, or wish to become pregnant
Data sourced from ClinicalTrials.gov (NCT00965757). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.