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

Rheumatoid Arthritis Clinical Trial

Official title:

Efficacy and Safety Study of Anbainuo in Chinese Patients With Rheumatoid Arthritis/ Ankylosing Spondylitis in the Real World: a Prospective, Open-label, Multi-center Observational Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03636984
• Other study ID #: Bioinno-ABN-2018001
• Status: Not yet recruiting
• Start date: August 24, 2018
• Est. completion date: December 24, 2020

Study information

• Verified date: August 2018
• Source: Zhejiang Hisun Pharmaceutical Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 24, 2020
• Est. primary completion date: July 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• recombinant TNF-a receptor: IgG Fc fusion protein
50mg weekly

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Hisun Pharmaceutical Co. Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of participants achieving clinical remission defined as a DAS28 =1.2	The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response (APR) determined as erythrocyte sedimentation rate (ESR), and general health (GH), both scored 1-100 (higher scores indicate higher disease activity). DAS28 was calculated according to the following formula: DAS28 equals (=) [0.56 multiplied by (*) the square root (v) of TJC] plus (+) [0.28 * v of SJC] + (0.70 * the natural logarithm (ln) ESR in millimeters per hour (mm/h)] + [0.014 * GH in mm visual analogue assessment (VAS)]. A negative change from randomization indicated improvement.	Up to week 48
Primary	Percent of participants achieving bath ankylosing spondylitis disease activity index (BASDAI) 50 response.	BASDAI subject assessment of discomfort, pain and fatigue was measured using a 100 millimeter Visual Analog Scale (VAS); range: 0=none to 100=very severe. BASDAI 50 response defined as at least a 50 percent (%) improvement (decrease) from baseline to observation (last observation carried forward) in the BASDAI. Baseline score minus score at observation divided by Baseline score * 100 = >=50%.	Up to week 48
Secondary	Change From baseline in the modified total Sharp score to week 48	he modified total sharp score is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions and joint space narrowing.	baseline and week 48