NCT00147966

Brief Summary

Using repeated arthroscopic biopsies of patients with rheumatoid arthritis, the researchers will assess changes in the immune response that occur as a result of treatment with rituximab.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Jun 2008

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

First Submitted

Initial submission to the registry

September 2, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
2.7 years until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
4 months until next milestone

Results Posted

Study results publicly available

March 23, 2010

Completed
Last Updated

March 23, 2010

Status Verified

June 1, 2008

Enrollment Period

1.5 years

First QC Date

September 2, 2005

Results QC Date

March 19, 2010

Last Update Submit

March 22, 2010

Conditions

Rheumatoid Arthritis

Keywords

active disease despite concomitant methotrexate

Outcome Measures

Primary Outcomes (1)

  • American College of Rheumatology (ACR) 20 at Week 12

    ACR 20, the American College of Rheumatology (ACR) definition of 20% improvement is based on a 20% improvement (compared to baseline values) in tender and swollen joint counts and 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function) and one acute phase reactant value (CRP).

    0 and 12 weeks

Study Arms (1)

ritxumab

EXPERIMENTAL

all patients get treatment

Drug: rituximab

Interventions

rituximabDRUG

treatment with rituximab

Also known as: rituxan
ritxumab

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Active rheumatoid arthritis
  • Use of concomitant methotrexate

You may not qualify if:

  • Use of disease-modifying anti-rheumatic drugs (DMARDs)/biologics other than methotrexate
  • Serious medical conditions that would preclude the use of the treating agent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD CIT

La Jolla, California, 92093, United States

Location

Related Publications (3)

  • Kavanaugh A, Rosengren S, Lee SJ, Hammaker D, Firestein GS, Kalunian K, Wei N, Boyle DL. Assessment of rituximab's immunomodulatory synovial effects (ARISE trial). 1: clinical and synovial biomarker results. Ann Rheum Dis. 2008 Mar;67(3):402-8. doi: 10.1136/ard.2007.074229. Epub 2007 Jul 20.

    PMID: 17644541BACKGROUND

  • Rosengren S, Wei N, Kalunian KC, Zvaifler NJ, Kavanaugh A, Boyle DL. Elevated autoantibody content in rheumatoid arthritis synovia with lymphoid aggregates and the effect of rituximab. Arthritis Res Ther. 2008;10(5):R105. doi: 10.1186/ar2497. Epub 2008 Sep 1.

    PMID: 18761748BACKGROUND

  • Rosengren S, Wei N, Kalunian KC, Kavanaugh A, Boyle DL. CXCL13: a novel biomarker of B-cell return following rituximab treatment and synovitis in patients with rheumatoid arthritis. Rheumatology (Oxford). 2011 Mar;50(3):603-10. doi: 10.1093/rheumatology/keq337. Epub 2010 Nov 23.

    PMID: 21098574DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Rituximab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Arthur Kavanaugh
Organization
UCSD
akavanaugh@ucsd.edu
858-657-7040

Study Officials

  • Arthur Kavanaugh, MD

    UCSD CIT

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 7, 2005

Study Start

June 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

March 23, 2010

Results First Posted

March 23, 2010

Record last verified: 2008-06

Locations

US(1)