Rheumatoid ArthritisLELANDNCT03508713
Long-term Prognosis and Quality of Life in Early Rheumatoid Arthritis Patients Treated by 2015 ACR Guideline (LELAND)
An observational study of Rheumatoid Arthritis, run by Nanfang Hospital, Southern Medical University.
Trial summary
To focus on the real world treat-to-target rate of early rheumatoid arthritis patients who will be treated according to the 2015 American College of Rheumatology Guideline for the Treatment of RA. To explore the factors which influence the treat-to-target outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- disease modified antirheumatic drugs or biological agents
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 13 May 2018to 1 Jul 2022
- 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: Participants entering this study are recruited from two hospital sites: Nanfang Hospital, Southern Medical University and Zhujiang Hospital, Southern Medical University.
Who may be able to join
- ≥18 years,
- be diagnosed with RA according to the 1987 or 2010 ACR criteria,
- in the course of the disease within 6 months,
- fill out questionnaires by oneself,
- fully understand the survey, agree to take part in the survey with signing the informed consent, and authority the researchers to expose and use his or her personal health information.
Who cannot join
- woman in pregnancy, lactation or plan to pregnant in the next 2 years,
- before enter this study, the patient joint any other RA clinical study in the past 24 weeks,
- according to the clinicians, one may not report his /or her life quality or the utilization of leading medical resources.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Long-term Prognosis and Quality of Life in Early Rheumatoid Arthritis Patients Treated by 2015 ACR Guideline (LELAND): a Multicenter Prospective Observational Study in Southern China
To focus on the real world treat-to-target rate of early rheumatoid arthritis patients who will be treated according to the 2015 American College of Rheumatology Guideline for the Treatment of RA.
To explore the factors which influence the treat-to-target outcome.
Read the detailed description
Resent study showed that rapid progression of cartilage and bone damage could happen on the early state of RA patients, so the clinicians should try the best to stop the trend, such as early diagnosis, early treatment and treat-to-target. But only half of the RA patients could reach low disease activity in the whole world and about 10% in China.
The investigators enroll early RA patients who are treated according to the 2015 American College of Rheumatology Guideline. The relevant data are collected and analyzed by the statistician including clinical data, imaging markers, blood samples and patient-reported outcomes every 3 months.
- Conditions
- Rheumatoid Arthritis
- Being tested
- disease modified antirheumatic drugs or biological agents
- Keywords
- Rheumatoid Arthritis, prognosis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
disease modified antirheumatic drugs or biological agentsDrug
Also called DMARDs, MTX, biologics
Enrolled patients will be treated according to the 2015 American College of Rheumatology Guideline for the Treatment of RA
| Study group | Role | What they receive |
|---|---|---|
| early RA patients | patients must fulfill the 1987 ACR classification criteria for rheumatoid arthritis or 2010 Rheumatoid arthritis classification criteria of ACR/EULAR, and meet the condition that the course of disease was no more than 6 months. If enrolled, patients will be treated with disease modified antirheumatic drugs or biological agents. Receives: Drug: disease modified antirheumatic drugs or biological agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of patients achieving treat to target
calculate the proportion of patients achieving treat to target according to the change of DAS28 score
Measured: 2018-4-25 to 2022-7-1
Secondary outcomes (4)
the change of Health Assessment Questionnaire Disability Index(HAQ-DI)
the change of Health Assessment Questionnaire Disability Index(HAQ-DI)
Measured: 2018-4-25 to 2022-7-1
the change of The Work Productivity and Activity Impairment Questionnaire(WPAI)
the change of The Work Productivity and Activity Impairment Questionnaire(WPAI)
Measured: 2018-4-25 to 2022-7-1
the change of European Quality of Life-5 Dimensions(EQ-5D)
the change of European Quality of Life-5 Dimensions(EQ-5D)
Measured: 2018-4-25 to 2022-7-1
the change of Short Form 36 Health Survey Questionnaire(SF-36)
the change of Short Form 36 Health Survey Questionnaire(SF-36)
Measured: 2018-4-25 to 2022-7-1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start13 May 2018 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Southern Medical University, China
- Responsible party
- Principal investigator, Min Yang, Nanfang Hospital, Southern Medical University
- Investigators
- Min Yang, doctor, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508713
- Sponsor's protocol ID
- LC2016PY020
- Acronym
- LELAND
- Status last verified
- May 2018
- First submitted
- 4 Jun 2017
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhao J, Zhan T, Zhu J, Fan M, Huang Q, Ren H, Wu J, Yu Q, Lin J, Ouyang Q, An S, Yang M. Long-term prognosis and quality of life in patients with early rheumatoid arthritis treated according to the 2015 ACR guideline (LELAND): protocol for a multicentre prospective observational study in Southern China. BMJ Open. 2018 Nov 15;8(11):e023798. doi: 10.1136/bmjopen-2018-023798.
PubMed 30446575
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Prognosis and Quality of Life in Early Rheumatoid Arthritis Patients Treated by 2015 ACR Guideline (LELAND): a Multicenter Prospective Observational Study in Southern China
- ClinicalTrials.gov ID
- NCT03508713
- Acronym / sponsor ID
- LELAND / LC2016PY020
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Southern Medical University, China
- Study start
- 13 May 2018 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 26 Apr 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.
To focus on the real world treat-to-target rate of early rheumatoid arthritis patients who will be treated according to the 2015 American College of Rheumatology Guideline for the Treatment of RA.
To explore the factors which influence the treat-to-target outcome.
Detailed description
Resent study showed that rapid progression of cartilage and bone damage could happen on the early state of RA patients, so the clinicians should try the best to stop the trend, such as early diagnosis, early treatment and treat-to-target. But only half of the RA patients could reach low disease activity in the whole world and about 10% in China.
The investigators enroll early RA patients who are treated according to the 2015 American College of Rheumatology Guideline. The relevant data are collected and analyzed by the statistician including clinical data, imaging markers, blood samples and patient-reported outcomes every 3 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| early RA patients | – | Drug: disease modified antirheumatic drugs or biological agentspatients must fulfill the 1987 ACR classification criteria for rheumatoid arthritis or 2010 Rheumatoid arthritis classification criteria of ACR/EULAR, and meet the condition that the course of disease was no more than 6 months. If enrolled, patients will be treated with disease modified antirheumatic drugs or biological agents. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants entering this study are recruited from two hospital sites: Nanfang Hospital, Southern Medical University and Zhujiang Hospital, Southern Medical University.
Key inclusion criteria (5 listed)
- ≥18 years,
- be diagnosed with RA according to the 1987 or 2010 ACR criteria,
- in the course of the disease within 6 months,
- fill out questionnaires by oneself,
- fully understand the survey, agree to take part in the survey with signing the informed consent, and authority the researchers to expose and use his or her personal health information.
Key exclusion criteria (3 listed)
- woman in pregnancy, lactation or plan to pregnant in the next 2 years,
- before enter this study, the patient joint any other RA clinical study in the past 24 weeks,
- according to the clinicians, one may not report his /or her life quality or the utilization of leading medical resources.
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 |
|---|---|---|
| disease modified antirheumatic drugs or biological agentsAlso: DMARDs, MTX, biologicsEnrolled patients will be treated according to the 2015 American College of Rheumatology Guideline for the Treatment of RA | Drug | early RA patients |
Primary outcome
the proportion of patients achieving treat to target
Time frame: 2018-4-25 to 2022-7-1
calculate the proportion of patients achieving treat to target according to the change of DAS28 score
4 secondary outcomes
the change of Health Assessment Questionnaire Disability Index(HAQ-DI)
Time frame: 2018-4-25 to 2022-7-1
the change of The Work Productivity and Activity Impairment Questionnaire(WPAI)
Time frame: 2018-4-25 to 2022-7-1
the change of European Quality of Life-5 Dimensions(EQ-5D)
Time frame: 2018-4-25 to 2022-7-1
the change of Short Form 36 Health Survey Questionnaire(SF-36)
Time frame: 2018-4-25 to 2022-7-1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
- Derived from this study: PubMed 30446575Zhao J, Zhan T, Zhu J, Fan M, Huang Q, Ren H, Wu J, Yu Q, Lin J, Ouyang Q, An S, Yang M. Long-term prognosis and quality of life in patients with early rheumatoid arthritis treated according to the 2015 ACR guideline (LELAND): protocol for a multicentre prospective observational study in Southern China. BMJ Open. 2018 Nov 15;8(11):e023798. doi: 10.1136/bmjopen-2018-023798.
- Individual participant dataSharing planned: No
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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.
Min Yang, doctor principal investigator
Nanfang Hospital, Southern Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Nanfang Hospital, Southern Medical University.
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 5 inclusion and 3 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 14 May 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?
Contact Min Yang, doctor (+86-13802911770, minyanggz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proportion of patients achieving treat to target (time frame: 2018-4-25 to 2022-7-1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03508713, which also lists 1 linked publication.
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 14 May 2018.