Phase 3
Completed N=327
Efficacy and Safety of Increased Dose of TA-650(Infliximab) in Patients With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT00691028 ↗Enrolled (actual)
327
Serious AEs
6.0%
Results posted
May 2013
Primary outcomePrimary: Numeric Index of American College of Rheumatology Response (ACR-N, N Shows the Percent Improvement) — 51.3; 53.8; 58.3 percent change
Summary
The purpose of this study is to assess the efficacy, safety and pharmacokinetics of maintenance treatment with 3mg/kg, 6mg/kg or 10mg/kg of TA-650 in combination with methotrexate (MTX) after three infusions (weeks-0, 2, 6) of 3mg/kg in Rheumatoid Arthritis (RA) showing an insufficient response to MTX.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numeric Index of American College of Rheumatology Response (ACR-N, N Shows the Percent Improvement) |
51.3; 53.8; 58.3 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 20, 50 and 70% Response (ACR20, 50, 70) |
75.8; 78.8; 82.7; 60.6; 58.7; 66.3 | — |
| SECONDARY Tender Joint Counts (TJC) |
18.6; 18.0; 17.5; 6.3; 4.8; 4.8 | — |
| SECONDARY Swollen Joint Count (SJC) |
14.2; 13.1; 13.7; 3.6; 3.3; 3.0 | — |
| SECONDARY CRP Level |
2.5; 2.3; 2.3; 0.5; 0.4; 0.2 | — |
| SECONDARY Change From Baseline in DAS28 |
-2.30; -2.57; -2.80 | — |
| SECONDARY Change From Baseline to Week 54 in HAQ |
-0.48; -0.56; -0.59 | — |
| SECONDARY Change in Modified Total Sharp Score (mTSS) at week54 From Baseline |
0.00; 0.48; 0.00 | — |
| SECONDARY Pharmacokinetics- Serum Concentration of Infliximab |
— | — |
| SECONDARY Pharmacokinetics Positive- ATI |
27; 24; 13 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with active RA in spite of stable dose of MTX
Exclusion Criteria
- Having received infliximab in the past
- Having a history of serious infection which caused hospitalization within 6 months before the registration
- Having an active tuberculosis
- Having a complication or a history of malignancy within 5 years before the registration
Data sourced from ClinicalTrials.gov (NCT00691028). 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.