A Study to Evaluate the Safety and Efficacy of SM03 in Patients With Rheumatoid Arthritis Receiving Methotrexate

Phase 2CompletedNCT04192617

SinoMab BioScience Ltd156 enrolled

Overview

This study evaluated the safety and efficacy of SM03 compared to placebo in patients with active rheumatoid arthritis(RA) receiving methotrexate

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

156

Conditions

Rheumatoid Arthritis

Interventions

SM03DRUG

SM03: 600 mg intravenous (IV)

PlaceboDRUG

Placebo: 600 mg intravenous (IV)

MethotrexateDRUG

methotrexate: 7.5-20 mg/week oral

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients 18-75 years of age. * Rheumatoid arthritis (RA) for ≥ 12 months, diagnosed according to the revised 1987 American College of Rheumatology (ACR) criteria for the classification of rheumatoid arthritis. * Moderate to severe active RA with swollen joint count (SJC) ≥ 8 (66 joint count), and tender joint count (TJC) ≥ 8 (68 joint count) at screening and baseline. * At screening, either C-reactive protein (CRP) ≥ 0.6 mg/dL (6 mg/L), 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 within past 6 months. * Concurrent treatment with any Disease Modifying Anti-Rheumatic Drug (DMARD) other than methotrexate * Active infection, or history of serious or chronic infection

Locations (1)

Peking Union Medical College Hostipal

Beijing, China

Outcomes

Primary Outcomes

Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24

To achieve an ACR20 required at least a 20% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 20% improvement in three of the following five additional measurements: * Physician's global assessment of disease activity (assessed using a 10 cm Visual Analog Scale \[VAS\]); * Patient's global assessment of disease activity (assessed using a 10 cm VAS); * Patient's assessment of pain (assessed using a 10 cm VAS); * Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3); * Acute phase reactant: C-reactive protein (CRP)

Time frame: Week 24

Secondary Outcomes

Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 4,8,12, 16

Time frame: Week 4,8,12,16

Percentage of Participants With an ACR50 Response at Week 24

To achieve an ACR50 required at least a 50% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 50% improvement in three of the following five additional measurements: * Physician's global assessment of disease activity (assessed using a 10 cm Visual Analog Scale \[VAS\]); * Patient's global assessment of disease activity (assessed using a 10 cm VAS); * Patient's assessment of pain (assessed using a 10 cm VAS); * Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3); * Acute phase reactant: C-reactive protein (CRP)

Data from ClinicalTrials.gov

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Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 24

A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score of less than or equal to 3.2. A Moderate Response is defined as either: an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 from Baseline and attainment of a DAS28 score of less than or equal to 5.1 or, an improvement (decrease) in the DAS28 of more than 1.2 from Baseline and attainment of a DAS28 score of greater than 3.2. No Response is defined as either an improvement (decrease) in the DAS28 of less than or equal to 0.6, or an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 of more than 5.1.

Time frame: Week 24