Status:
UNKNOWN
A Study Assessing the Efficacy and Safety of SM03 in Patients With Active Rheumatoid Arthritis Receiving MTX
Lead Sponsor:
SinoMab BioScience Ltd
Conditions:
Rheumatoid Arthritis(RA)
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
* To demonstrate that SM03 added to methotrexate (MTX) reduce signs and symptoms of rheumatoid arthritis (RA) in Chinese RA participants with an inadequate response to MTX. * To assess the safety of S...
Detailed Description
The total duration of study was expected up to 58 weeks (screening period of 6 weeks, randomized treatment period of 24 weeks and open-label treatment extention period of 24 weeks , and a 4-week post ...
Eligibility Criteria
Inclusion
- Adult patients 18-75 years of age.
- Rheumatoid arthritis (RA) for ≥ 6 months, diagnosed according to the revised 1987 American College of Rheumatology (ACR) criteria, or 2010 ACR/EULAR for the classification of rheumatoid arthritis.
- Moderate to severe active RA with swollen joint count (SJC) ≥ 6(66 joint count), and tender joint count (TJC) ≥ 8 (68 joint count) at screening and baseline.
- At screening, either High sensitivity C-Reactive Protein (hs-CRP) ≥ 1.5 UNL, or Erythrocyte sedimentation rate (ESR) ≥ 28 mm/hour, or Morning stiffness of joint for ≥ 45 minutes.
- Inadequate response to methotrexate, having received and tolerated at a dose of 7.5-20 mg/week for ≥ 12 weeks, at a stable dose over the past 4 weeks.
Exclusion
- Rheumatic autoimmune disease other than RA.
- Use of any biological DMARDs for RA.
- Concurrent treatment with any Disease Modifying Anti-Rheumatic Drug (DMARD) other than methotrexate
- Active infection, or history of serious or chronic infection
- The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Key Trial Info
Start Date :
December 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2022
Estimated Enrollment :
510 Patients enrolled
Trial Details
Trial ID
NCT04312815
Start Date
December 28 2017
End Date
July 1 2022
Last Update
January 8 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking Union Medical College Hostipal
Beijing, China, 100032