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NCT03636984
Efficacy and Safety Study of Anbainuo in Chinese Patients With RA/AS in the Real World
trial testing recombinant TNF-α receptor: IgG Fc fusion protein in Rheumatoid Arthritis in 1,000 participants. Status unknown.
24 July 2020
Quick facts
| Lead sponsor | Zhejiang Hisun Pharmaceutical Co. Ltd. |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 1,000 |
| Start date | 24 August 2018 |
| Primary completion | 24 July 2020 |
| Estimated completion | 24 December 2020 |
Drugs / interventions tested
- recombinant TNF-α receptor: IgG Fc fusion protein — full drug profile →
Conditions studied
- Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →
- Ankylosing Spondylitis — all drugs for Ankylosing Spondylitis →
Sponsor
Zhejiang Hisun Pharmaceutical Co. Ltd. — full company profile →
Who can join
18 and older, any sex, with Rheumatoid Arthritis or Ankylosing Spondylitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03636984
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03636984 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Zhejiang Hisun Pharmaceutical Co. Ltd.
- Last refreshed: 17 August 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03636984.
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