Clinical trial NCT01617590: Disease-Modifying Antirheumatic Drugs Cycle Combination Therapy Research
Official title: A 48-week, Multi-center, Randomized, Open-lable, Controlled Study to Assess the Response (ACR20) Using Different Disease-Modifying Antirheumatic Drugs Cycle Combination Regimen in Adult Patients With Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: RA
Leflunomide
Methotrexate
Lead sponsor: Shanxi Medical University
Sponsor class: OTHER
First posted: 2012-06-12
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was intended to assess the efficacy and safety of different Disease-Modifying Antirheumatic Drugs cycle combination regimen using the American College of Rheumatology (ACR) criteria of 20% improvement in symptoms (ACR20) in managing active adult rheumatoid arthritis.


Eligibility criteria: Inclusion Criteria:

RA patients：

* Male and female patients aged 18 - 75 years (inclusive).
* Body weight between 50 and 100 kg (inclusive).
* Post menopausal or surgically sterile female patients are allowed. Female patients of child-bearing potential may participate if they are already on a stable dose of methotrexate. Additional birth control details to be provided at screening. Male patients must use an effective contraception method during the study and at least for 2 months following the completion/discontinuation of the study.
* Diagnosis of RA, classified by American Rheumatism Association 1987 revised criteria.
* Active disease evaluation (DAS 28 \> 3.2).
* Patients who using steroids before enrollment, the dose should not be more than 30mg/d, and remain unchanged for more than 30days.
* Without use of other disease activity controlling drugs.
* Get the informed consent.

Exclusion Criteria:

* Advanced patients with severe joints disability.
* Pregnant or breast- feeding female patients.
* Patients with severe primary disease or impairment of heart, brain, lung, liver (ALT or AST \> 1.5 normal value), kidney (sCr \> normal value), endocrine, and hematology system.
* Concomitant with other rheumatic disease.
* Alcohol taken or drug abusing patients.
* Patients with congestive heart failure, QT prolongation syndrome or poorly controlled diabetes mellitus. Patients with a history of QTc prolongation will be excluded.
* Patients who have received intra-articular or systemic corticosteroid injections having been required for treatment of acute RA flare (not being part of a regular therapeutic regimen) within 4 weeks prior to randomization.

Primary outcomes:
measure: ACR20
timeFrame: 48 weeks
Secondary outcomes:
measure: ACR50
timeFrame: 48 weeks
measure: ACR70
timeFrame: 48week
measure: EULAR response：good response
timeFrame: 48 week
measure: EULAR response ：moderate response
timeFrame: 48 week
Other outcomes:
Locations:
city: TaiYuan
country: China
facility: rheumatism department,Second hospital of Shanxi medical university
state: Shanxi
Study officials:
affiliation: Second Hospital of Shanxi Medical University
name: li xiao feng
role: PRINCIPAL_INVESTIGATOR
References: