Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2025-12-27 @ 12:21 PM
Study NCT ID:
NCT04704492
Status:
COMPLETED
Last Update Posted:
2021-01-11
First Post:
2021-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Pharmacokinetics and Safety of SM03 in Patients With Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2013-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-08', 'studyFirstSubmitDate': '2021-01-06', 'studyFirstSubmitQcDate': '2021-01-08', 'lastUpdatePostDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-12-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants Positive for Anti-Drug Antibody (ADA)', 'timeFrame': 'Week 0,4,8,12', 'description': 'Serum ADA positivity is determined over course of the trial duration'}, {'measure': 'Change From Baseline in CD19+ B-cell Count During the Study Period', 'timeFrame': 'Week 0,4,8,12', 'description': 'Pharmacodynamic endpoint: change from baseline in CD19+ B-cell count during the study period'}], 'primaryOutcomes': [{'measure': 'Area Under the Concentration Time Cure(AUC0-t)', 'timeFrame': 'Week 0 to 12', 'description': 'Pharmacokinetic endpoint: Area Under the Concentration Time Cure(AUC0-t)'}, {'measure': 'Time to Maximum Plasma Concentration (Tmax)', 'timeFrame': 'Week 0,2', 'description': 'Pharmacokinetic endpoint: Time to Maximum Plasma Concentration (Tmax)'}, {'measure': 'Peak Plasma Concentration (Cmax)', 'timeFrame': 'Week 0, 2', 'description': 'Pharmacokinetic endpoint: Peak Plasma Concentration (Cmax)'}, {'measure': 'Systemic Clearance (CL)', 'timeFrame': 'Week 0 to 12', 'description': 'Pharmacokinetic endpoint: Systemic Clearance (CL)'}, {'measure': 'Terminal Half-life (T1/2)', 'timeFrame': 'Week 0 to 12', 'description': 'Pharmacokinetic endpoint:Terminal Half-life (T1/2)'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Experienced at Least One Adverse Event', 'timeFrame': 'Week 0 to 12', 'description': 'An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.'}, {'measure': 'Number of ACR20, ACR50, and ACR70 Responders at Week 12', 'timeFrame': 'Week 2,4,8,12', 'description': 'American College of Rheumatology (ACR) Responder Index is based on a set of evaluations: the Investigator Tender Joint Count/Number of Tender Joints (out of 68 Joints); Investigator Swollen Joint Count/Number of Swollen Joints (out of 66 Joints); Patient Global Assessment of Disease Activity (PGAD); Investigator Global Assessment of Disease Activity (IGAD); Patient Global Assessment of Pain (PGAP); Health Assessment Questionnaire Disability Index (HAQ-DI); and ESR. ACR response indicates percent change (ie, improvement) from baseline (20%, 50%, 70%) PGAD \\& IGAD'}, {'measure': 'Change From Baseline in Disease Activity Score (DAS28-ESR) at Week 12', 'timeFrame': 'Week 0,2,4,8,12', 'description': "The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:\n\nThe number of swollen and tender joints assessed using the 28-joint count; Erythrocyte sedimentation rate (ESR); Patient's global assessment of disease activity measured on a 10 cm visual analog scale.\n\nThe DAS28 score ranges from zero to ten. A DAS28 score above 5.1 means high disease activity whereas a DAS28 less than or equal to 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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 participant, including a screening period of maximally 4 weeks, a multiple-dose period of 2 weeks (day 0 \\~ day 14), and a post-treatment follow-up period of 10 weeks (day 15 \\~ day 84).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Rheumatoid arthritis (RA) for ≥ 6 months, diagnosed according to the revised 1987 American College of Rheumatology (ACR) criteria for the classification of rheumatoid arthritis.\n* 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.\n* 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.\n* Receiving methotrexate (MTX) 7.5 - 25mg/week (oral) for at least 12 weeks, at a stable dose over the past 4 weeks.\n\nExclusion Criteria:\n\n* Females who are pregnant, breastfeeding, or planning a pregnancy during the Treatment Period of and 12 months after the last infusion of study drug.\n* Rheumatic autoimmune disease other than RA.\n* Use of any biological DMARDs for RA within past 6 months.\n* Active infection, or history of serious or chronic infection.\n* Any significant cardiac disease, moderate to severe chronic obstructive pulmonary disease.\n* Allergy or sensitivity to components of the drug vial or any of the materials used for infusion'}, 'identificationModule': {'nctId': 'NCT04704492', 'briefTitle': 'A Study of the Pharmacokinetics and Safety of SM03 in Patients With Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'SinoMab BioScience Ltd'}, 'officialTitle': 'An Open-label, Multiple-dose Study to Assess the Pharmacokinetics, Pharmacodynamics, Preliminary Clinical Activity and Safety of Human Mouse Chimeric Anti-CD22 Monoclonal Antibody (SM03) in Patients With Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'SM03-RA(I/II)-1.0'}, 'secondaryIdInfos': [{'id': 'CTR20131127', 'type': 'OTHER', 'domain': 'chinadrugtrials.org.cn'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biological: SM03', 'description': 'Biological: SM03 600 mg or 900 mg intravenous (IV) on week 0 , 2.', 'interventionNames': ['Drug: Biological: SM03']}], 'interventions': [{'name': 'Biological: SM03', 'type': 'DRUG', 'otherNames': ['SM03'], 'description': 'Biological: SM03 600 mg or 900 mg intravenous (IV) on week 0,2', 'armGroupLabels': ['Biological: SM03']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100032', 'city': 'Beijing', 'country': 'China', 'facility': 'Clinical Pharmacology Research Center & Translational Medicine Centre, Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Pei Hu, PhD,MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Pharmacology Research Center & Translational Medicine Centre, Peking Union Medical College Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SinoMab BioScience Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}