NCT00162201

Brief Summary

Study to assess changes in synovial tissue before and after treatment with Abatacept in subjects with RA who remained on their background disease modifying anti-arthritis medications but who have failed previous therapy with anti-TNF (tumor necrosing factor)blocking agents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Oct 2003

Typical duration for phase_1 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

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

October 1, 2003

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
Last Updated

January 12, 2017

Status Verified

April 1, 2011

Enrollment Period

1.5 years

First QC Date

September 9, 2005

Last Update Submit

January 11, 2017

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Comparison of each subject's synovial tissue markers

    at baseline and after 4 months of treatment with abatacept

Secondary Outcomes (2)

  • assess baseline & post treatment synovitis by dynamic gadolinium enhanced MRI; determine concentrations of abatacept in synovial fluid & serum

    after 4 months of treatment

  • assess safety & tolerability of abatacept

    administered for 4 months

Study Arms (1)

1

EXPERIMENTAL
Drug: Abatacept

Interventions

AbataceptDRUG

Parenteral, IV, 500 mg if \< 60 kg; 750 mg if \> 60 \& \< 100 kg; 1000 mg if \> 100 kg, Monthly, 4 months.

Also known as: Orencia
1

Eligibility Criteria

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

You may qualify if:

  • RA for at least 1 year
  • Clear clinical signs of active RA in 1 knee joint
  • Meet ARA (1987) criteria for diagnosis of RA and ACR (1991) criteria for RA functional classes I, II, or III
  • Inadequate clinical response to a minimum of 3 months of therapy with anti-TNF-blocking agents
  • Taking background DMARDs for a minimum of 3 months and at stable doses for at least 28 days

You may not qualify if:

  • Serious bacterial infection in last 3 months
  • History of TB
  • History of cancer within 5 years
  • Evidence of latent or active bacterial or viral infection
  • Intra-articular corticosteroids within 3 months
  • Exposure to live vaccines
  • Exposure to CTLA4Ig or BMS-188667
  • Treatment with immunoadsorption column(s), mycophenolate mofetil, leflunomide, anakinra, cyclosporine, etanercept, adalimumab, infliximab, azathioprine, oral or parenteral gold, D-penacillamine, calcineurin inhibitors, cyclophosphamide or other alkylating agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Leeds, Essex, United Kingdom

Location

Related Publications (1)

  • Buch MH, Boyle DL, Rosengren S, Saleem B, Reece RJ, Rhodes LA, Radjenovic A, English A, Tang H, Vratsanos G, O'Connor P, Firestein GS, Emery P. Mode of action of abatacept in rheumatoid arthritis patients having failed tumour necrosis factor blockade: a histological, gene expression and dynamic magnetic resonance imaging pilot study. Ann Rheum Dis. 2009 Jul;68(7):1220-7. doi: 10.1136/ard.2008.091876. Epub 2008 Sep 4.

    PMID: 18772191BACKGROUND

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Abatacept

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ImmunoconjugatesAntibodiesImmunoglobulinsSerum GlobulinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsGlobulins

Study Officials

  • Bristol Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 13, 2005

Study Start

October 1, 2003

Primary Completion

April 1, 2005

Study Completion

April 1, 2005

Last Updated

January 12, 2017

Record last verified: 2011-04

Locations

GB(1)