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A Single Dose Clinical Trial to Study the Safety of ART-I02 in Patients With Arthritis

NCT02727764 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-11-14

No results posted yet for this 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 2/5 vector in subjects with Rheumatoid Arthritis (RA) or Osteoarthritis (OA) and active arthritis of the carpometacarpal (CMC), metacarpophalangeal (MCP), proximal interphalangeal (PIP), or distal interphalangeal (DIP) joints.

Conditions

  • Arthritis, Rheumatoid
  • Osteo Arthritis

Interventions

GENETIC

ART-I02

Single Intra-articular injection in the carpometacarpal (CMC), metacarpophalangeal (MCP), proximal interphalangeal (PIP), or distal interphalangeal (DIP) joint

Sponsors & Collaborators

  • Centre for Human Drug Research (CHDR)

    collaborator UNKNOWN

  • Arthrogen

    lead INDUSTRY

Principal Investigators

  • Koos Burggraaf, PhD · Principal Investigator

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-20
Primary Completion
2022-09-30
Completion
2022-09-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02727764 on ClinicalTrials.gov