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

NCT04312815 | Unknown Phase 3

• 1 other identifier: SM03-RA-III-V4.0
• Study Type: interventional
• Target: 510
• Locations: 1 country
• Sites: 1

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

Conditions

Rheumatoid Arthritis(RA)

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 (5)

• Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 12,52

  Week 12,52

• Percentage of Participants With an ACR50/ACR70 Response at Week 12,24,52

  Week 12,24,52

• Change From Baseline in Disease Activity Score (DAS28-ESR) at Week 12,24,52

  Baseline and Week12,24,52

• Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 12,24,52

  Baseline and Week12,24,52

• Percentage of Participants With Adverse Events

  For Placebo arm: Baseline up to week 24; For SM03 arm: Baseline up to week 52;

Study Arms (2)

SM03 600 mg

EXPERIMENTAL

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.

Drug: SM03; Drug: MTX

Placebo

PLACEBO COMPARATOR

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.

Drug: SM03; Drug: Placebo; Drug: MTX

Interventions

SM03 DRUG

SM03: 600 mg intravenous (IV)

Placebo; SM03 600 mg

Placebo DRUG

Placebo: 600 mg intravenous (IV)

Placebo

MTX DRUG

Methotrexate: 7.5-20 mg/wk oral

Placebo; SM03 600 mg

Eligibility Criteria

• Age: 18 Years - 70 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 ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SinoMab BioScience Ltd: lead

Study Sites (1)

Peking Union Medical College Hostipal

Beijing, 100032, China

RECRUITING

Related Publications (1)

• Wong KL, Li Z, Ma F, Wang D, Song N, Chong CH, Luk KK, Leung SO. SM03, an Anti-CD22 Antibody, Converts Cis-to-Trans Ligand Binding of CD22 against alpha2,6-Linked Sialic Acid Glycans and Immunomodulates Systemic Autoimmune Diseases. J Immunol. 2022 Jun 15;208(12):2726-2737. doi: 10.4049/jimmunol.2100820. Epub 2022 Jun 10.

  PMID: 35688465 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

• Xiaofeng Zeng, MD

  Department of Rheumatology and Immunology, Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Nie, Ms

CONTACT

(86)755-26611079; niexin@sinomab.com

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: March 16, 2020
• First Posted: March 18, 2020
• Study Start: December 28, 2017
• Primary Completion: December 1, 2021
• Study Completion: July 1, 2022
• Last Updated: January 8, 2021

Record last verified: 2021-01

Locations

CN (1)