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Efficacy and Safety of Adalimumab in Patients With Active Rheumatoid Arthritis Treated Concomitantly With Methotrexate.

2014-07-23 21:48:11 | BioPortfolio

Summary

The purpose of the study is to assess the safety, immunogenicity and clinical efficacy of adalimumab in combination with methotrexate for patients with rheumatoid arthritis.

Description

This study has an initial 52-week treatment period, followed by an open-label extension phase up to 10 years in duration.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Rheumatoid Arthritis

Intervention

Adalimumab, Adalimumab, Placebo

Location

Huntsville
Alabama
United States
35801

Status

Active, not recruiting

Source

Abbott

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:48:11-0400

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A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis

To evaluate the inhibition of radiographic progression in joint destruction of adalimumab compared to placebo in adult Japanese subjects with rheumatoid arthritis.

A Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)

This is a phase 3, randomized, double-blind study comparing ABT-494 to Placebo and to Adalimumab in subjects with moderately to severely active rheumatoid arthritis who are on a stable bac...

Assessment of the Effect of Adalimumab on Response to Influenza Virus and Pneumococcal Vaccines in Subjects With Rheumatoid Arthritis

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A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis

The purpose of this study is to determine the effectiveness and safety, over 6 months, of 5 doses of CP-690,550 for the treatment of adults with active rheumatoid arthritis. Five out of s...

Adalimumab Administered in Korean Rheumatoid Arthritis Subjects Treated With Methotrexate

The purpose of the study is to assess the safety and efficacy of adalimumab compared to placebo in subjects with rheumatoid arthritis on methotrexate therapy.

PubMed Articles [1914 Associated PubMed Articles listed on BioPortfolio]

Patient-reported outcomes for tofacitinib with and without methotrexate, or adalimumab with methotrexate, in rheumatoid arthritis: a phase IIIB/IV trial.

To provide the first direct comparison of patient-reported outcomes (PROs) following treatment with tofacitinib monotherapy versus tofacitinib or adalimumab (ADA) in combination with methotrexate (MTX...

Anti-adalimumab antibodies kinetics: an early guide for juvenile idiopathic arthritis (JIA) switching.

To assess the longitudinal production of anti-adalimumab antibody (AAA) and baseline risk factors for this antibody development in juvenile idiopathic arthritis (JIA) patients initiating adalimumab (A...

Safety and efficacy of switching from adalimumab to sarilumab in patients with rheumatoid arthritis in the ongoing MONARCH open-label extension.

Evaluate open-label sarilumab monotherapy in patients with rheumatoid arthritis switching from adalimumab monotherapy in MONARCH (NCT02332590); assess long-term safety and efficacy in patients continu...

Early adalimumab and anti-adalimumab antibody levels for prediction of primary nonresponse in ankylosing spondylitis patients.

This study aimed at exploring the concentration-effect relationship of adalimumab and early adalimumab and anti-adalimumab antibodies (AAA) levels in predicting primary nonresponse in a real-world pil...

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Biological drugs are an alternative to treatment of psoriasis and psoriatic arthritis. Adalimumab is a representative of the anti-TNF group. The underlying of this disease is a cellular homeostasis di...

Medical and Biotech [MESH] Definitions

A humanized monoclonal antibody that binds specifically to TNF-ALPHA and blocks its interaction with endogenous TNF RECEPTORS to modulate INFLAMMATION. It is used in the treatment of RHEUMATOID ARTHRITIS; PSORIATIC ARTHRITIS; CROHN'S DISEASE and ULCERATIVE COLITIS.

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.

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