Rheumatoid ArthritisNCT03636984
Efficacy and Safety Study of Anbainuo in Chinese Patients With RA/AS in the Real World
An observational study of Rheumatoid Arthritis and Ankylosing Spondylitis, run by Zhejiang Hisun Pharmaceutical Co. Ltd..
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Ankylosing Spondylitis
- What is being tested?
- recombinant TNF-α receptor: IgG Fc fusion protein
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 24 Aug 2018to 24 Dec 2020
- How long will I take part?
- 48 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: RA and AS patients from 30 centers (hospital) in China.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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
- Being tested
- recombinant TNF-α receptor: IgG Fc fusion protein
- Medical subject headings
- Arthritis, Rheumatoid, Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant TNF-α receptor: IgG Fc fusion proteinDrug
Also called Anbainuo
50mg weekly
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: recombinant TNF-α receptor: IgG Fc fusion protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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%.
Measured: Up to week 48
Secondary outcomes (1)
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.
Measured: baseline and week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start24 Aug 2018 (estimated)
- Primary completion24 Jul 2020 (estimated)
- Study completion24 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 48 Weeks
Sponsor and investigators
- Lead sponsor
- Zhejiang Hisun Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636984
- Sponsor's protocol ID
- Bioinno-ABN-2018001
- Status last verified
- Aug 2018
- First submitted
- 13 Aug 2018
- Last updated
- 17 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03636984
- Acronym / sponsor ID
- Bioinno-ABN-2018001
- Conditions
- Rheumatoid Arthritis, Ankylosing Spondylitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Zhejiang Hisun Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Aug 2018 (estimated)
- Primary completion
- 24 Jul 2020 (estimated)
- Study completion
- 24 Dec 2020 (estimated)
- First posted
- 17 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 48 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rheumatoid arthritis patients | – | Drug: recombinant TNF-α receptor: IgG Fc fusion proteinsubjects 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. |
| ankylosing spondylitis patients | – | Drug: recombinant TNF-α receptor: IgG Fc fusion proteinsubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- RA and AS patients from 30 centers (hospital) in China.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recombinant TNF-α receptor: IgG Fc fusion proteinAlso: Anbainuo50mg weekly | Drug | ankylosing spondylitis patients, rheumatoid arthritis patients |
Primary outcome
Percent of participants achieving clinical remission defined as a DAS28 ≥1.2
Time frame: Up to week 48
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.
Percent of participants achieving bath ankylosing spondylitis disease activity index (BASDAI) 50 response.
Time frame: Up to week 48
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%.
1 secondary outcome
Change From baseline in the modified total Sharp score to week 48
Time frame: baseline and week 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Ankylosing Spondylitis, run by Zhejiang Hisun Pharmaceutical Co. Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of participants achieving clinical remission defined as a DAS28 ≥1.2 (time frame: Up to week 48). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018.