Efficacy and Safety Study of Anbainuo in Chinese Patients With RA/AS in the Real World

NCT ID: NCT03636984

Last Updated: 2018-08-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-24
• Study Completion Date: 2020-12-24

Brief Summary

TNF- α receptor inhibitors have been used widely in practice and are well developed in China. Anbainuo is a bio-similar recombinant TNF-α receptor: IgG Fc fusion protein, approved in 2015. Up to now, Anbainuo is well applied in patients with rheumatoid arthritis (RA) or ankylosing spondylitis (AS). Although the phase II and III clinical trials both indicated that Anbainuo can effectively control the disease activity with good tolerance and safety in RA and AS patients, there is no sufficient clinical evidence in the real world. Thus, the objective of this study is to evaluate, under the actual conditions of use, dosing patterns of Anbainuo. Investigators plan to recruit 1000 adult patients with RA or AS and to follow them for 48 weeks. It is hypothesized that this study would reflect real clinical conditions (efficacy and safety assessment) of using Anbainuo in RA and AS patients.

Conditions

Rheumatoid Arthritis; Ankylosing Spondylitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

rheumatoid arthritis patients

subjects with rheumatoid arthritis would be administered with recombinant TNF-α receptor: IgG Fc fusion protein （Anbainuo）50 mg peer week for 3 to 6 months until reaching clinical remission or low disease activity. Then the application of Anbainuo would be continued for 6 months. If the subjects did not reach clinical remission or low disease activity in 6 months, the treatment should be considered as invalid.

recombinant TNF-α receptor: IgG Fc fusion protein

Intervention Type: DRUG

50mg weekly

ankylosing spondylitis patients

subjects with ankylosing spondylitis would be administered with recombinant TNF-α receptor: IgG Fc fusion protein （Anbainuo）50 mg peer week for 3 to 6 months until reaching clinical remission or low disease activity. Then the application of Anbainuo would be continued for 6 months. If the subjects did not reach clinical remission or low disease activity in 6 months, the treatment should be considered as invalid.

recombinant TNF-α receptor: IgG Fc fusion protein

Intervention Type: DRUG

50mg weekly

Interventions

recombinant TNF-α receptor: IgG Fc fusion protein

50mg weekly

Intervention Type: DRUG

Other Intervention Names

Anbainuo

Eligibility Criteria

Inclusion Criteria

• meet the diagnostic criteria of the American College of Rheumatology (ACR) (1987);
• or meet the diagnostic criteria of ankylosing spondylitis (New York, modified in 1984);
• older than 18;
• Prepare to or already start to use Anbainuo.

Exclusion Criteria

• any acute or chronic infection or the history of active tuberculosis
• pregnant women or breast feeding women;
• malignant tumor;
• moderate to severe congestive heart failure (New York Heart Association, 3-4 grade);
• allergic to Anbainuo.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Hisun Pharmaceutical Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Bioinno-ABN-2018001

Identifier Type: -

Identifier Source: org_study_id