Rheumatoid ArthritisNCT05240859
Real World Study of a Adalimumab Biosimilar (Geleli) in Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Peking University People's Hospital at 1 site in China.
Trial summary
The purpose of this multicenter, prospective, Observational study is to assess the Efficacy and Safety of an Adalimumab Biosimilar (Geleli) in Rheumatoid Arthritis in the real world setting. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Geleli
- How many people
- 1,600 participants
- Where
- 1 siteChina
- Study dates
- 22 Feb 2022to 30 Aug 2024
- How long will I take part?
- 6 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: RA patients who start Geleli treatment
Who may be able to join
- Participants who fulfilled the 1987 revised American College of Rheumatology (ACR) or 2010 ACR/EULAR classification criteria for RA.
- Participants for whom the rheumatologists have decided to initiate Geleli treatment.
- Participants who provide a written informed consent form of participating in this study.
Who cannot join
- Current active or chronic infections, or previous history of active TB infection.
- History of malignancy.
- Congestive heart failure with NYHA class III or IV.
- Females of childbearing or breastfeeding.
- Participate in other clinical trial within 3 months.
- Allergic to the drugs involved in the study.
- The investigator believes that the patient is not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, 100044
Zhanguo Li, MD, PhD, +86 88324178, li99@bjmu.edu.cn
About this study
Official title: A Multicenter, Prospective, Observational Real World Study For the Efficacy and Safety of a Adalimumab Biosimilar (Geleli) in Rheumatoid Arthritis.
The purpose of this multicenter, prospective, Observational study is to assess the Efficacy and Safety of an Adalimumab Biosimilar (Geleli) in Rheumatoid Arthritis in the real world setting.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Geleli
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GeleliDrug
Adalimumab Biosimilar
| Study group | Role | What they receive |
|---|---|---|
| Geleli | RA patients treated with Geleli Receives: Drug: Geleli |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Achieving American College of Rheumatology (ACR) 20
The ACR20 was achieved if there was at least a 20% improvement from baseline in swollen joint count 66 (SJC66) and tender joint count 68 (TJC68) and 3 or more of the 5 following assessments: participant's assessment of pain, GH, physician's global assessment of disease activity, participant's assessment of physical function and CRP.
Measured: Week 24
Secondary outcomes (9)
Percentage of Participants Who Were on Geleli for a Period of 24 Weeks
Measured: Week 24
Remission rate According to Boolean Criteria
Measured: Week 12 and Week 24
Remission rate According to Clinical Disease Activity Index (CDAI)
Measured: Week 12 and Week 24
Proportion of Participants Achieving American College of Rheumatology (ACR) 20
Measured: Week 4 and Week 12
Proportion of Participants Achieving American College of Rheumatology (ACR) 50
Measured: Week 4, Week 12 and Week 24
Proportion of Participants Achieving American College of Rheumatology (ACR) 70
Measured: Week 4, Week 12 and Week 24
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR
Measured: Baseline, Week 4, Week12 and Week 24
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Measured: Baseline, Week 4, Week12 and Week 24
Assessment of Safety Based on Adverse Events that Occur During the Study.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start22 Feb 2022 (estimated)
- Primary completion28 Feb 2024 (estimated)
- Study completion30 Aug 2024 (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.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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
- 1,600 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhanguo Li, MD, PhD, Principal investigator, Department of Rheumatology and Immunology, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240859
- Sponsor's protocol ID
- 2022-Z-04
- Status last verified
- Feb 2022
- First submitted
- 6 Feb 2022
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Observational Real World Study For the Efficacy and Safety of a Adalimumab Biosimilar (Geleli) in Rheumatoid Arthritis.
- ClinicalTrials.gov ID
- NCT05240859
- Acronym / sponsor ID
- 2022-Z-04
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 22 Feb 2022 (estimated)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 15 Feb 2022 (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.
The purpose of this multicenter, prospective, Observational study is to assess the Efficacy and Safety of an Adalimumab Biosimilar (Geleli) in Rheumatoid Arthritis in the real world setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geleli | – | Drug: GeleliRA patients treated with Geleli |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- RA patients who start Geleli treatment
Key inclusion criteria (3 listed)
- Participants who fulfilled the 1987 revised American College of Rheumatology (ACR) or 2010 ACR/EULAR classification criteria for RA.
- Participants for whom the rheumatologists have decided to initiate Geleli treatment.
- Participants who provide a written informed consent form of participating in this study.
Key exclusion criteria (7 listed)
- Current active or chronic infections, or previous history of active TB infection.
- History of malignancy.
- Congestive heart failure with NYHA class III or IV.
- Females of childbearing or breastfeeding.
- Participate in other clinical trial within 3 months.
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 |
|---|---|---|
| GeleliAdalimumab Biosimilar | Drug | Geleli |
Primary outcome
Proportion of Participants Achieving American College of Rheumatology (ACR) 20
Time frame: Week 24
The ACR20 was achieved if there was at least a 20% improvement from baseline in swollen joint count 66 (SJC66) and tender joint count 68 (TJC68) and 3 or more of the 5 following assessments: participant's assessment of pain, GH, physician's global assessment of disease activity, participant's assessment of physical function and CRP.
9 secondary outcomes
Percentage of Participants Who Were on Geleli for a Period of 24 Weeks
Time frame: Week 24
Remission rate According to Boolean Criteria
Time frame: Week 12 and Week 24
Remission rate According to Clinical Disease Activity Index (CDAI)
Time frame: Week 12 and Week 24
Proportion of Participants Achieving American College of Rheumatology (ACR) 20
Time frame: Week 4 and Week 12
Proportion of Participants Achieving American College of Rheumatology (ACR) 50
Time frame: Week 4, Week 12 and Week 24
Proportion of Participants Achieving American College of Rheumatology (ACR) 70
Time frame: Week 4, Week 12 and Week 24
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR
Time frame: Baseline, Week 4, Week12 and Week 24
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Time frame: Baseline, Week 4, Week12 and Week 24
Assessment of Safety Based on Adverse Events that Occur During the Study.
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
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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.
Zhanguo Li, MD, PhD principal investigator
Department of Rheumatology and Immunology, Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Peking University People's Hospital at 1 site in China.
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 3 inclusion and 7 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 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Ru Li, MD, PhD (+86 18611616251, doctorliru123@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Achieving American College of Rheumatology (ACR) 20 (time frame: Week 24). 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 15 Feb 2022.