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

Hisun Pharmaceutical

Status: Unknown

Conditions: Ankylosing Spondylitis; Rheumatoid Arthritis

Treatments: Drug: recombinant TNF-α receptor: IgG Fc fusion protein

Study type: Observational

Funder types: Industry

Identifiers

NCT03636984

Bioinno-ABN-2018001

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,000 participants in 2 patient groups

rheumatoid arthritis patients

Description:

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.

Treatment:

Drug: recombinant TNF-α receptor: IgG Fc fusion protein

ankylosing spondylitis patients

Description:

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.

Treatment:

Drug: recombinant TNF-α receptor: IgG Fc fusion protein