Other Clinical Trial - A Study of the Efficacy & Safety of TACI-antibody

A Study of the Efficacy and Safety of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Inadequate Response to MTX Due to Treat Moderate and Severe Rheumatoid Arthritis.

Moderate and Severe RheumatoId Arthritis Clinical Trial

Official title:
A Phase III Study of RC18,a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Poor Efficacy of MTX Due to Treat Moderate and Severe Rheumatoid Arthritis.

Clinical Trial Summary

The purpose of this study is to initially access the safety and effectivity of RC18 combined with methotrexate (MTX) in comparison with the use of methotrexate alone in participants with moderate to severe Rheumatoid Arthritis (RA) who have an inadequate response to MTX therapy.

See also
	Status	Clinical Trial	Phase
	Terminated	`NCT02882087` - A Study of the Efficacy and Safety of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Inadequate Response to TNF-α Antagonists Due to Treat Moderate and Severe Rheumatoid Arthritis	Phase 2

See also

Status

Clinical Trial

Phase

Terminated

NCT02882087 - A Study of the Efficacy and Safety of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Inadequate Response to TNF-α Antagonists Due to Treat Moderate and Severe Rheumatoid Arthritis

Phase 2

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT03016013
Study type	Interventional
Source	RemeGen Co., Ltd.
Contact
Status	Completed
Phase	Phase 3
Start date	April 5, 2017
Completion date	December 29, 2022

A Study of the Efficacy and Safety of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Inadequate Response to MTX Due to Treat Moderate and Severe Rheumatoid Arthritis.

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms