Clinical trial NCT02320630: Combination Therapy Prevents the Relapse of RA
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Recurrence (Disease Attribute)
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Peking University People's Hospital
name: Peking University Third Hospital
name: Beijing Hospital
name: Beijing Jishuitan Hospital
name: Peking University Shougang Hospital
name: Beijing Shijitan Hospital, Capital Medical University
First posted: 2014-12-19
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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)

Eligibility criteria: Inclusion Criteria:

* Fulfill 2010 EULAR/ACR RA dignose criteria
* Age18-70 years old
* Have been teated regularly for 3 months
* Disease duration \> 6months
* DAS28\>3.2

Exclusion Criteria:

* 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
* 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.

Primary outcomes:
measure: the rate of recurrence
timeFrame: 60 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Rheumatology and Immunology Department,Peking University First Hospital
state: Beijing
Study officials:
References:
citation: Zhao 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.
citation: Fan 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.