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

NCT04192617 | Completed Phase 2

• 1 other identifier: SM03-RA-II-V3.3
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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)

  Week 24

Secondary Outcomes (6)

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

  Week 4,8,12,16

• Percentage of Participants With an ACR50 Response at Week 24

  Week 24

• Percentage of Participants With an ACR70 Response at Week 24

  Week 24

• Change From Baseline in Disease Activity Score (DAS28-ESR) at Week 24

  Baseline and Week 24

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

  Week 24

Study Arms (3)

SM03 600 mg*2

EXPERIMENTAL

SM03: 600 mg intravenous (IV) on week 0,2, and week 12,14; placebo: 600 mg intravenous (IV) on week 4 and16; Methotrexate: 7.5-20 mg/wk oral.

Drug: SM03; Drug: Placebo; Drug: Methotrexate

SM03 600 mg*3

EXPERIMENTAL

SM03: 600 mg intravenous (IV) on week 0,2, 4, and week 12,14,16; Methotrexate: 7.5-20 mg/wk oral.

Drug: SM03; Drug: Methotrexate

placebo*3

PLACEBO COMPARATOR

placebo: 600 mg intravenous (IV) on week 0,2, 4, and week 12,14,16; Methotrexate: 7.5-20 mg/wk oral.

Drug: Placebo; Drug: Methotrexate

Interventions

SM03 DRUG

SM03: 600 mg intravenous (IV)

SM03 600 mg*2; SM03 600 mg*3

Placebo DRUG

Placebo: 600 mg intravenous (IV)

SM03 600 mg*2; placebo*3

Methotrexate DRUG

methotrexate: 7.5-20 mg/week oral

SM03 600 mg*2; SM03 600 mg*3; placebo*3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• SinoMab BioScience Ltd: lead

Study Sites (1)

Peking Union Medical College Hostipal

Beijing, 100032, China

Location

Related Publications (1)

• Li J, Li M, Wu D, Zhou J, Leung SO, Zhang F. SM03, an anti-human CD22 monoclonal antibody, for active rheumatoid arthritis: a phase II, randomized, double-blind, placebo-controlled study. Rheumatology (Oxford). 2022 May 5;61(5):1841-1848. doi: 10.1093/rheumatology/keab699.

  PMID: 34508557 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 10, 2019
• Study Start: December 31, 2014
• Primary Completion: February 3, 2016
• Study Completion: February 3, 2016
• Last Updated: December 10, 2019

Record last verified: 2019-12

Locations

CN (1)