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Virus Therapy

Cohort II for Rheumatoid Arthritis

Phase 1
Waitlist Available
Led By William O Martin, PhD
Research Sponsored by Arthrogen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This study will evaluate the safety and tolerability of a single intra-articular administration of ART-I02 (AAV5.NF-kB.IFN-β), a recombinant adeno-associated virus (AAV) type 5 vector in subjects with RA and active arthritis of a wrist.

Eligible Conditions
  • Rheumatoid Arthritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Treatment emergent (serious) adverse events
Secondary outcome measures
Change from baseline after single dose of ART-I02 on hand function measured by Grip strength measurement in the target and contralateral joint.
Change from baseline after single dose of ART-I02 on hand function measured by VAS function in the target and contralateral joint.
Change from baseline after single dose of ART-I02 on hand function measured by VAS pain in the target and contralateral joint.
+15 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort IIIExperimental Treatment1 Intervention
Single intra-articular injection in the wrist joint of ART-I02 Maximum Tolerated Dose (MTD) as assessed in cohorts I and II:
Group II: Cohort IIExperimental Treatment1 Intervention
Single intra-articular injection of ART-I02: 2.4x10E13 vg / wrist joint
Group III: Cohort IExperimental Treatment1 Intervention
Single intra-articular injection ART-I02: 2.4x10E12 vg / wrist joint

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Who is running the clinical trial?

ArthrogenLead Sponsor
1 Previous Clinical Trials
12 Total Patients Enrolled
William O Martin, PhDPrincipal InvestigatorUniversity Of Calagary

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
ART-I02 in Patients With Rheumatoid Arthritis With Inflamed Wrists
2018. "ART-I02 in Patients With Rheumatoid Arthritis With Inflamed Wrists". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03445715.
All > Rheumatoid Arthritis > Ra
~2 spots leftby Apr 2025
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