NCT00617032

Brief Summary

Study 1304 is a Phase I dose escalation study conducted in adults with persistent moderate (grade 2) or severe (grade 3) swelling due to inflammatory arthritis (rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis) in at least one peripheral joint eligible for injection. Disease must not be severe enough to warrant use of a TNF-alpha antagonist in the next three months. Current use of TNF-alpha antagonists is not permitted. Subjects with rheumatoid arthritis must have had an adequate trial of at least one disease-modifying antirheumatic drug (DMARD) prior to screening. The primary objective is to evaluate the safety of intra-articular administration of tgAAC94.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Feb 2004

Typical duration for phase_1 rheumatoid-arthritis

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 15, 2008

Completed
Last Updated

February 15, 2008

Status Verified

February 1, 2008

Enrollment Period

1.8 years

First QC Date

February 5, 2008

Last Update Submit

February 5, 2008

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (3)

  • Serious adverse events

    From study drug administration through final study visit

  • Severe or very severe adverse events

    From study drug administration through final study visit

  • Study drug-related adverse events

    From study drug administration through final study visit

Secondary Outcomes (7)

  • Change in tenderness and swelling of injected joint

    Days 3 and 7 and Weeks 2, 4, 8, and 12

  • Change in tenderness and swelling of non-injected joints

    Weeks 2, 4, and 12

  • Reduction in disease activity, as measured by American College of Rheumatology (ACR) criteria and Disease Activity Score (DAS)

    Weeks 2, 4, and 12

  • Joint fluid measures (cell count and differential, total protein and TNFR:Fc protein)

    Weeks 4 and 12

  • TNFR:Fc protein levels in serum

    Day 7 and Weeks 2, 4, 8, and 12

  • +2 more secondary outcomes

Study Arms (3)

1

ACTIVE COMPARATOR

1x10\^10 DRP/mL tgAAC94

Genetic: tgAAC94 gene therapy vector

2

ACTIVE COMPARATOR

1x10\^11 DRP/mL tgAAC94

Genetic: tgAAC94 gene therapy vector

3

PLACEBO COMPARATOR

Single dose tgAAC94 placebo

Genetic: tgAAC94 placebo

Interventions

tgAAC94 gene therapy vectorGENETIC

Single Dose 1x10\^10 DNase resistant particles (DRP) / mL joint volume

1
tgAAC94 placeboGENETIC

Single dose

3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis, diagnosed according to published criteria
  • Persistent moderate (grade 2) or sever (grade 3) swelling due to inflammatory arthritis in at least one peripheral joint eligible for injection
  • For subjects with rheumatoid arthritis, an adequate trial of at least one disease-modifying antirheumatic drug (DMARD) prior to screening
  • For subjects currently on DMARD(s), a stable regimen for inflammatory arthritis for the previous three months, with no changes in doses in the four weeks prior to screening
  • Age greater than 18 years
  • Be willing to practice effective birth control measures during the study, if of reproductive ability
  • Able to give written informed consent

You may not qualify if:

  • Current use of a TNF-alpha antagonist
  • Disease severe enough to warrant use of a systemic TNF-alpha antagonist in the next three months
  • Discontinuation of TNF-alpha antagonists in the past because of safety concerns
  • Current use of anakinra
  • Poor functional status, defined as being bed-bound or wheelchair-bound
  • Corticosteriod therapy at doses higher than the equivalent of 10 mg prednisone per day
  • Any of the following laboratory values: Hemoglobin \<8.5 gm/dL, white blood cell count \<3500 per mm\^3, platelet \<100 K/microL, creatinine \>2 mg/dL, bilirubin \>2 mg/dL, AST or ALT \>2 times the upper limit of normal, or abnormal coagulation profiles
  • Known HIV infection, known hepatitis C infection, or known positive serologic test for hepatitis B surface antigen
  • Positive PPD, unless previously treated with appropriate prophylaxis
  • Pregnancy or lactation, either at the time of screening or planned in the next six months
  • Inflammatory bowel disease, such as Crohn's disease or ulcerative colitis
  • Serious medical disease, such as sever liver or kidney disease, uncompensated congestive heart failure, myocardial infarction within six months, unstable angina, uncontrolled hypertension, severe pulmonary disease or active asthma, demyelinating neurological disease, history of cancer (other than cutaneous basal and squamous cell carcinoma) with less than five years documentation of a disease free state, insulin-dependent diabetes, recurrent opportunistic infections or other concurrent medical condition that, in the opinion of the investigator, would make the subject unsuitable for the study
  • Unlikely to comply with the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

UCLA Division of Rheumatology

Los Angeles, California, United States

Location

Denver Arthritis Research Center

Denver, Colorado, United States

Location

Swedish Rheumoatology Research

Seattle, Washington, United States

Location

Arthritis Research Centre of Canada

Vancouver, British Columbia, Canada

Location

Arthritis Centre Clinical Research Unit UofManitoba

Winnipeg, Manitoba, Canada

Location

Mt Sinai Hospital

Toronto, Ontario, Canada

Location

Toronto Western Hospital

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Alison Heald, MD

    Targeted Genetics Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 5, 2008

First Posted

February 15, 2008

Study Start

February 1, 2004

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

February 15, 2008

Record last verified: 2008-02

Locations

US(3)CA(4)