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A Study of the Safety and Efficacy of Intravenous CNTO 148 (Golimumab) in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

2014-08-27 03:43:08 | BioPortfolio

Summary

The primary purpose of this study is to assess the clinical effectiveness and safety of intravenous (IV- injection directly into the vein) golimumab infusions every 12 weeks in patients with active rheumatoid arthritis (RA) despite current MTX treatment. The secondary objectives of this study are to evaluate the effects on physical function, quality of life, and the pharmacological features of golimumab in subjects with active RA.

Description

Though subcutaneously (SC- injections under the skin) administered golimumab has been shown to be effective in the treatment of RA, no large (Phase 3) clinical trial has yet been performed to support the use of or to determine the optimal dosage for maximal safety and effectiveness of golimumab when administered intravenously (into the vein). Such information would be important to physicians and patients who prefer IV administration of anti-TNF therapy to SC administration. The main purpose of this study is to assess the effects of golimumab on patients with Rheumatoid Arthritis. This study will assess the safety of intravenously administered golimumab and determine if there is a reduction of signs and symptoms (such as pain, stiffness, and tender and swollen joints) in patients with active Rheumatoid Arthritis who have been on a stable dose of Methotrexate (MTX) treatment. The effect of intravenously administered golimumab on physical function and the quality of life in patients with Rheumatoid Arthritis will also be assessed. This is a study of efficacy (effectiveness) and safety of IV administration of golimumab at 2 different doses (given with or without MTX) for at least 48 weeks in patients with active RA despite current MTX therapy. Patients will receive 30 minute infusions of either 2 mg/kg or 4 mg/kg golimumab or placebo (sham) every 12 weeks. Doses of study drugs may be changed at Weeks 16 and/or 24 based upon how well individual patients respond to treatment. In the majority of cases, patients randomized (based on chance) to placebo will begin receiving 4 mg/kg golimumab infusions at Week 24.The study drugs received by the patients will remain unknown to patients and investigators until the last patient completes the Week 48 visit. The trial hypothesis is that the study treatment (2 mg/kg and/or 4 mg/kg golimumab with and/or without MTX) will be more effective in treatment of RA than MTX alone, as measured by >=50 percent improvement from baseline in American College of Rheumatology(ACR) scores at Week 14 (including number of tender and swollen joints) without any significant adverse events. Other measurements include DAS28 (Disease Activity Score including a 28-joint count) using CRP (C-Reactive Protein blood test) at week 14. Patients will receive a 30-minute IV infusion of either 2 mg/kg or 4 mg/kg golimumab or placebo at Weeks 0, 12 and 24, 36 and 48 with or without methotrexate. Most placebo patients will receive 4 mg/kg golimumab every 12 weeks beginning at Week 24.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Rheumatoid Arthritis

Intervention

golimumab; methotrexate, golimumab; methotrexate, golimumab; methotrexate, golimumab; placebo, placebo; methotrexate, golimumab; placebo

Status

Completed

Source

Centocor, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:43:08-0400

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