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

SinoMab Bioscience

Status and phase: Unknown; Phase 3

Conditions: Rheumatoid Arthritis(RA)

Treatments: Drug: Placebo; Drug: MTX; Drug: SM03

Study type: Interventional

Funder types: Industry

Identifiers

NCT04312815

SM03-RA-III-V4.0

Details and patient eligibility

About

• 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

Full 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 treatment observation).

Enrollment: 510 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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510 participants in 2 patient groups, including a placebo group

SM03 600 mg

Experimental group

Description:

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.

Treatment:

Drug: MTX

Drug: SM03

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: MTX

Drug: SM03