Recurrence (Disease Attribute)NCT02320630
Combination Therapy Prevents the Relapse of RA
A study testing Entanercept, HCQ and MTX in people with Recurrence (Disease Attribute), run by Peking University First Hospital at 1 site in China.
Trial summary
This trial aims to compare the cost effective and effect of preventing recurrence by different treatment of TFP and HCQ combined SSZ for remittent RA. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Recurrence (Disease Attribute)
- What is being tested?
- Entanercept, HCQ and MTX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Sep 2020
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fulfill 2010 EULAR/ACR RA dignose criteria
- Age18-70 years old
- Have been teated regularly for 3 months
- Disease duration > 6months
- DAS28>3.2
Who cannot join
- Received surgical operation in 8 weeks
- Received other biological agent (eg. rituximab, anti-TNF agents, anti-IL6 agents)in 6 months;
- Injection of steroid in 4 weeks
- Coexisting with other CTD except for SS
- With severe and not controled cardiac vescular disease, neurological disease, pulmonary disease (including COPD and ILD), renal disease, liver disease, endocrine disease and Gastric Intestinal Disease
- With not controled diseases including asthma, IBD and psoriasis needing oral or injection of steroid
Show all 14Show fewer
- Active infection with T>38℃. Patients need admitted into hospital or biotics injection in 4 weeks or need oral biotics in 2 weeks
- Malignant history.
- Serum creatinine >130 µmol/L
- AST/ALT higher than 2 times upper level
- platelet count<100 x 109/L，or white blood count<3 x 109/L
- Interstitail lung disease: Chest X Ray
- Hands X Ray ACR radiology staging shows IV stage RA
- Pregnancy or planing to pregnant in 2 years or suckling period women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Rheumatology and Immunology Department,Peking University First Hospital
Beijing, Beijing Municipality, 100034
Zhuoli Zhang, Pro, 13901094780, zhuoli.zhang@126.com
About this study
Official title: The Efficacy, Safety and Cost-effectiveness of Hydroxychloroquine, Sulfasalazine, Methotrexate Triple Therapy in Preventing Relapse Among Patients With Rheumatoid Arthritis Achieving Clinical Remission or Low Disease Activity
This trial aims to compare the cost effective and effect of preventing recurrence by different treatment of TFP and HCQ combined SSZ for remittent RA.
Read the detailed description
patients were divided into 3groups: Group A:TFP+MTX (week0-week60) Group B:TFP+MTX+HCQ+SSZ(week0-week12) and then MTX+HCQ+SSZ(week13-week60) Group C:TFP+MTX (week0-week12) and then MTX (week13-week60)
- Conditions
- Recurrence (Disease Attribute)
- Being tested
- Entanercept, HCQ, MTX
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EntanerceptDrug
Also called MTX
Both Entanercept and MTX were given to patients for 60weeks (Week0-Week60).
HCQDrug
Also called SSZ, MTX, TFP
Combination of HCQ+SSZ+MTX were given to patients for 60weeks (Week0-Week60).Entanercept was given to patients for 12 weeks (Week0-Week12).
MTXDrug
Also called Entanercept
MTX was given to patients for 60weeks (Week0-Week60). Entanercept was given to patients for 12 weeks (Week0-Week12).
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Maintenance treatment group Receives: Drug: Entanercept; Drug: MTX |
| B | Experimental | Combination treatment group Receives: Drug: Entanercept; Drug: HCQ; Drug: MTX |
| C | Experimental | Single drug group Receives: Drug: Entanercept; Drug: MTX |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of recurrence
Measured: 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startOct 2015
- Primary completionFeb 2017
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Recurrence (Disease Attribute)Studies of the same condition, open and under way.
- More trials run by Peking University First 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University People's Hospital, Peking University Third Hospital, Beijing Hospital, Beijing Jishuitan Hospital, Peking University Shougang Hospital, Beijing Shijitan Hospital, Capital Medical University
- Responsible party
- Principal investigator, Zhuoli Zhang, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320630
- Sponsor's protocol ID
- PUCRP201305
- Status last verified
- Jun 2020
- First submitted
- 16 Dec 2014
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhao J, Zhou W, Wu Y, Yan X, Yang L, Zhang Z. Efficacy, safety, and cost-effectiveness of triple therapy in preventing relapse in rheumatoid arthritis: A randomized controlled trial (ESCoRT study). Chin Med J (Engl). 2022 Sep 20;135(18):2200-2209. doi: 10.1097/CM9.0000000000002336.
PubMed 36525606Zhao J, Zhou W, Wu Y, Ji P, Yang L, Yan X, Zhang Z. The efficacy, safety and cost-effectiveness of hydroxychloroquine, sulfasalazine, methotrexate triple therapy in preventing relapse among patients with rheumatoid arthritis achieving clinical remission or low disease activity: the study protocol of a randomized controlled clinical Trial (ESCoRT study). BMC Med Inform Decis Mak. 2021 Mar 4;21(1):83. doi: 10.1186/s12911-021-01449-2.
PubMed 33663487Fan Y, Yang X, Zhao J, Sun X, Xie W, Huang Y, Li G, Hao Y, Zhang Z. Cysteine-rich 61 (Cyr61): a biomarker reflecting disease activity in rheumatoid arthritis. Arthritis Res Ther. 2019 May 21;21(1):123. doi: 10.1186/s13075-019-1906-y.
PubMed 31113467
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy, Safety and Cost-effectiveness of Hydroxychloroquine, Sulfasalazine, Methotrexate Triple Therapy in Preventing Relapse Among Patients With Rheumatoid Arthritis Achieving Clinical Remission or Low Disease Activity
- ClinicalTrials.gov ID
- NCT02320630
- Acronym / sponsor ID
- PUCRP201305
- Conditions
- Recurrence (Disease Attribute)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Peking University People's Hospital, Peking University Third Hospital, Beijing Hospital, Beijing Jishuitan Hospital, Peking University Shougang Hospital, Beijing Shijitan Hospital, Capital Medical University
- Study start
- Oct 2015 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Sep 2020 (estimated)
- First posted
- 19 Dec 2014 (estimated)
- 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.
This trial aims to compare the cost effective and effect of preventing recurrence by different treatment of TFP and HCQ combined SSZ for remittent RA.
Detailed description
patients were divided into 3groups: Group A:TFP+MTX (week0-week60) Group B:TFP+MTX+HCQ+SSZ(week0-week12) and then MTX+HCQ+SSZ(week13-week60) Group C:TFP+MTX (week0-week12) and then MTX (week13-week60)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Entanercept, Drug: MTXMaintenance treatment group |
| B | Experimental | Drug: Entanercept, Drug: HCQ, Drug: MTXCombination treatment group |
| C | Experimental | Drug: Entanercept, Drug: MTXSingle drug group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Fulfill 2010 EULAR/ACR RA dignose criteria
- Age18-70 years old
- Have been teated regularly for 3 months
- Disease duration > 6months
- DAS28>3.2
Key exclusion criteria (14 listed)
- Received surgical operation in 8 weeks
- Received other biological agent (eg. rituximab, anti-TNF agents, anti-IL6 agents)in 6 months;
- Injection of steroid in 4 weeks
- Coexisting with other CTD except for SS
- With severe and not controled cardiac vescular disease, neurological disease, pulmonary disease (including COPD and ILD), renal disease, liver disease, endocrine disease and Gastric Intestinal Disease
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 |
|---|---|---|
| EntanerceptAlso: MTXBoth Entanercept and MTX were given to patients for 60weeks (Week0-Week60). | Drug | A, B, C |
| HCQAlso: SSZ, MTX, TFPCombination of HCQ+SSZ+MTX were given to patients for 60weeks (Week0-Week60).Entanercept was given to patients for 12 weeks (Week0-Week12). | Drug | B |
| MTXAlso: EntanerceptMTX was given to patients for 60weeks (Week0-Week60). Entanercept was given to patients for 12 weeks (Week0-Week12). | Drug | A, B, C |
Primary outcome
the rate of recurrence
Time frame: 60 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
- Derived from this study: PubMed 36525606Zhao J, Zhou W, Wu Y, Yan X, Yang L, Zhang Z. Efficacy, safety, and cost-effectiveness of triple therapy in preventing relapse in rheumatoid arthritis: A randomized controlled trial (ESCoRT study). Chin Med J (Engl). 2022 Sep 20;135(18):2200-2209. doi: 10.1097/CM9.0000000000002336.
- Derived from this study: PubMed 33663487Zhao J, Zhou W, Wu Y, Ji P, Yang L, Yan X, Zhang Z. The efficacy, safety and cost-effectiveness of hydroxychloroquine, sulfasalazine, methotrexate triple therapy in preventing relapse among patients with rheumatoid arthritis achieving clinical remission or low disease activity: the study protocol of a randomized controlled clinical Trial (ESCoRT study). BMC Med Inform Decis Mak. 2021 Mar 4;21(1):83. doi: 10.1186/s12911-021-01449-2.
- Derived from this study: PubMed 31113467Fan Y, Yang X, Zhao J, Sun X, Xie W, Huang Y, Li G, Hao Y, Zhang Z. Cysteine-rich 61 (Cyr61): a biomarker reflecting disease activity in rheumatoid arthritis. Arthritis Res Ther. 2019 May 21;21(1):123. doi: 10.1186/s13075-019-1906-y.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Entanercept, HCQ and MTX in people with Recurrence (Disease Attribute), run by Peking University First 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 5 inclusion and 14 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 22 Jun 2020. 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 Zhuoli Zhang, Pro. (13901094780, zhuoli.zhang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of recurrence (time frame: 60 weeks). 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 NCT02320630, which also lists 3 linked publications.
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 22 Jun 2020.