A Study Assessing the Efficacy and Safety of SM03 in Patients With Active Rheumatoid Arthritis Receiving MTX

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

510 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-28

Study Completion Date

2022-07-31

Brief Summary

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* 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 SM03 added to MTX in Chinese RA participants with an inadequate response to MTX

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Detailed Description

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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 treatment observation).

Conditions

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Rheumatoid Arthritis(RA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SM03 600 mg

SM03: 600 mg intravenous (IV) Randomizd period:on week 0,2,4 and 12,14,16;Participants with inadequate response (defined as less than 10% improvement from baseline in TJC and SJC by Week 12) were rescued with open label SM03 600 mg IV treatment.

Open-lable treatment on week 24,30,36,42,48; Methotrexate: 7.5-20 mg/wk oral.

Group Type EXPERIMENTAL

SM03

Intervention Type DRUG

SM03: 600 mg intravenous (IV)

MTX

Intervention Type DRUG

Methotrexate: 7.5-20 mg/wk oral

Placebo

placebo: 600 mg intravenous (IV) on week 0,2, 4, and week 12,14,16;Participants with inadequate response (defined as less than 10% improvement from baseline in TJC and SJC by Week 12) were rescued with open label SM03 600 mg IV treatment.

SM03: 600 mg intravenous (IV) on week 24,30,36,42,48; Methotrexate: 7.5-20 mg/wk oral.

Group Type PLACEBO_COMPARATOR

SM03

Intervention Type DRUG

SM03: 600 mg intravenous (IV)

Placebo

Intervention Type DRUG

Placebo: 600 mg intravenous (IV)

MTX

Intervention Type DRUG

Methotrexate: 7.5-20 mg/wk oral

Interventions

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SM03

SM03: 600 mg intravenous (IV)

Intervention Type DRUG

Placebo

Placebo: 600 mg intravenous (IV)

Intervention Type DRUG

MTX

Methotrexate: 7.5-20 mg/wk oral

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No