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

NCT03636984 | Unknown

• 1 other identifier: Bioinno-ABN-2018001
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 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 (=) \[0.56 multiplied by (\*) the square root (√) of TJC\] plus (+) \[0.28 \* √ of SJC\] + (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

• 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 Outcomes (1)

• Change From baseline in the modified total Sharp score to week 48

  baseline and week 48

Study Arms (2)

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.

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

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.

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

Interventions

recombinant TNF-α receptor: IgG Fc fusion protein DRUG

50mg weekly

Also known as: Anbainuo

ankylosing spondylitis patients; rheumatoid arthritis patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

RA and AS patients from 30 centers (hospital) in China.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Hisun Pharmaceutical Co. Ltd.: lead

MeSH Terms

Conditions

Arthritis, Rheumatoid; Spondylitis, Ankylosing

Interventions

Anbainuo protein, human

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 48 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 17, 2018
• Study Start: August 24, 2018
• Primary Completion: July 24, 2020
• Study Completion: December 24, 2020
• Last Updated: August 17, 2018

Record last verified: 2018-08