MedDataX Logo

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

NCT ID: NCT04192617

Last Updated: 2019-12-10

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-02-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rheumatoid Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SM03 600 mg*2

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.

Group Type EXPERIMENTAL

SM03

Intervention Type DRUG

SM03: 600 mg intravenous (IV)

Placebo

Intervention Type DRUG

Placebo: 600 mg intravenous (IV)

Methotrexate

Intervention Type DRUG

methotrexate: 7.5-20 mg/week oral

SM03 600 mg*3

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

Group Type EXPERIMENTAL

SM03

Intervention Type DRUG

SM03: 600 mg intravenous (IV)

Methotrexate

Intervention Type DRUG

methotrexate: 7.5-20 mg/week oral

placebo*3

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo: 600 mg intravenous (IV)

Methotrexate

Intervention Type DRUG

methotrexate: 7.5-20 mg/week oral

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SM03

SM03: 600 mg intravenous (IV)

Intervention Type DRUG

Placebo

Placebo: 600 mg intravenous (IV)

Intervention Type DRUG

Methotrexate

methotrexate: 7.5-20 mg/week oral

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

SinoMab BioScience Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Peking Union Medical College Hostipal

Beijing, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 34508557 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SM03-RA-II-V3.3

Identifier Type: -

Identifier Source: org_study_id