Status:
COMPLETED
A Study of the Pharmacokinetics and Safety of SM03 in Patients With Rheumatoid Arthritis
Lead Sponsor:
SinoMab BioScience Ltd
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This was an open phase I trial to evaluate the pharmacokinetic, pharmacodynamic, safety and clinical activity profiles of anti-CD22 monoclonal antibody SM03 in patients with active RA.
Detailed Description
This was an open phase I trial to evaluate the PK, PD, safety,tolerability, efficacy, and immunogenicity of SM03 in patients with RA. The total study duration was approximately 16 weeks for each parti...
Eligibility Criteria
Inclusion
- Rheumatoid arthritis (RA) for ≥ 6 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) ≥ 6 (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.
- Receiving methotrexate (MTX) 7.5 - 25mg/week (oral) for at least 12 weeks, at a stable dose over the past 4 weeks.
Exclusion
- Females who are pregnant, breastfeeding, or planning a pregnancy during the Treatment Period of and 12 months after the last infusion of study drug.
- Rheumatic autoimmune disease other than RA.
- Use of any biological DMARDs for RA within past 6 months.
- Active infection, or history of serious or chronic infection.
- Any significant cardiac disease, moderate to severe chronic obstructive pulmonary disease.
- Allergy or sensitivity to components of the drug vial or any of the materials used for infusion
Key Trial Info
Start Date :
August 14 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2013
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04704492
Start Date
August 14 2012
End Date
December 16 2013
Last Update
January 11 2021
Active Locations (1)
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1
Clinical Pharmacology Research Center & Translational Medicine Centre, Peking Union Medical College Hospital
Beijing, China, 100032