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A Safety and Efficacy Study of Golimumab (CNTO148) in Patients With Active Rheumatoid Arthritis (RA)

2014-08-27 03:27:02 | BioPortfolio

Summary

The purpose of this study is to evaluate the safety and effectiveness of golimumab in patients with active rheumatoid arthritis despite DMARD (Disease-modifying antirheumatic drugs) therapy. Another objective is to evaluate the pharmacokinetics of golimumab.

Description

This study is designed as a placebo-controlled study of golimumab monotherapy for the purpose of demonstrating the safety and effectiveness of golimumab, a new, fully human anti-TNF (Tumor necrosis factor) a monoclonal antibody produced by mean of HuMab mouse technology. Other reasons for using the study design are as follows: the effects of golimumab given alone must be confirmed as in the case of other drugs; and golimumab may be used even in patients not on the treatment with MTX. CNTO148 50 mg group: CNTO148 50 mg SC injections every 4 weeks from the first administration until week 116 CNTO148 100 mg group: CNTO148 100 mg SC injections every 4 weeks from the first administration until week 116. Placebo group: Placebo SC injections every 4 weeks from the first administration until week 12 and then CNTO148 50mg SC injections every 4 weeks from week 16 until week 116

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Rheumatoid Arthritis

Intervention

CNTO148 ; Golimumab

Status

Active, not recruiting

Source

Janssen Pharmaceutical K.K.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:27:02-0400

Clinical Trials [1395 Associated Clinical Trials listed on BioPortfolio]

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

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 wi...

A Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Golimumab in Patients With Rheumatoid Arthritis (RA)

This is a Phase 1, pharmacokinetic and pharmacodynamic study of intravenous and subcutaneous administered golimumab in patients with rheumatoid arthritis.

A Study of the Safety and Efficacy of Golimumab in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy

The purpose of this study is to evaluate the efficacy and safety of golimumab, alone or in combination with methotrexate, as compared to methotrexate alone in rheumatoid arthritis subjects...

A Study of the Safety and Efficacy of Golimumab in Subjects With Rheumatoid Arthritis That Are Methotrexate-Naive

The purpose of this study is to evaluate the efficacy and safety of golimumab, alone or in combination with methotrexate, as compared to methotrexate alone in rheumatoid arthritis subjects...

Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129AM2)

Part 1 of this trial will assess the safety and effectiveness of subcutaneous (SC) golimumab administered by autoinjector once monthly, when combined with different disease-modifying antir...

PubMed Articles [1159 Associated PubMed Articles listed on BioPortfolio]

The Effectiveness of Intravenous Golimumab Administered Directly After Infliximab in Rheumatoid Arthritis Patients.

For patients with rheumatoid arthritis (RA) who do not respond or lose response to anti-tumor necrosis factor (TNF) biologics, switching to a different anti-TNF can be an effective means to manage sym...

Efficacy and safety of golimumab as add-on therapy to standard disease-modifying antirheumatic drugs: Results of the GO-MORE study in the Polish population.

The GO-MORE study was an open-label, multinational, prospective study that investigated the efficacy and safety of adding golimumab to synthetic disease-modifying antirheumatic drugs (sDMARDs) in pati...

MICB*002 and MICB*014 protect against rheumatoid arthritis, whereas MICA*009 and MICA*A6 are associated with rheumatoid arthritis in a Hainan Han Chinese population.

Rheumatoid arthritis (RA) as an inflammatory autoimmune disease affects the synovial joints as well as other organs and tissues. Since aberrant expression of MIC molecules has been observed in RA pati...

Methotrexate did not improve endothelial function in rheumatoid arthritis: a study in rats with adjuvant-induced arthritis.

Rheumatoid arthritis is associated with an increased cardiovascular risk, secondary to endothelial dysfunction. There is accumulating evidence that methotrexate reduces cardiovascular risk in rheumato...

Effects of TNF-α in rheumatoid arthritis via attenuating α1 (I) collagen promoter.

To explore the role of TNF-α in the peripheral blood of patients with rheumatoid arthritis (RA) and its underlying mechanism.

Medical and Biotech [MESH] Definitions

Arthritis in children, with onset before 16 years of age. The terms juvenile rheumatoid arthritis (JRA) and juvenile idiopathic arthritis (JIA) refer to classification systems for chronic arthritis in children. Only one subtype of juvenile arthritis (polyarticular-onset, rheumatoid factor-positive) clinically resembles adult rheumatoid arthritis and is considered its childhood equivalent.

Rheumatoid arthritis of children occurring in three major subtypes defined by the symptoms present during the first six months following onset: systemic-onset (Still's Disease, Juvenile-Onset), polyarticular-onset, and pauciarticular-onset. Adult-onset cases of Still's disease (STILL'S DISEASE, ADULT-ONSET) are also known. Only one subtype of juvenile rheumatoid arthritis (polyarticular-onset, rheumatoid factor-positive) clinically resembles adult rheumatoid arthritis and is considered its childhood equivalent.

A variable mixture of the mono- and disodium salts of gold thiomalic acid used mainly for its anti-inflammatory action in the treatment of rheumatoid arthritis. It is most effective in active progressive rheumatoid arthritis and of little or no value in the presence of extensive deformities or in the treatment of other forms of arthritis.

Systemic-onset rheumatoid arthritis in adults. It differs from classical rheumatoid arthritis in that it is more often marked by acute febrile onset, and generalized lymphadenopathy and hepatosplenomegaly are more prominent.

Antibodies found in adult RHEUMATOID ARTHRITIS patients that are directed against GAMMA-CHAIN IMMUNOGLOBULINS.

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