Phase I/II Multiple-Dose LEA29Y vs CTLAG4Ig vs Placebo in Rheumatoid Arthritis

A Pilot, Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety, Preliminary Clinical Activity and Immunogenicity of Multiple Doses of LEA29Y and CTLA4Ig Administered Intravenously to Subjects With Rheumatoid Arthritis

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00279760

Enrollment

210

Registered

2006-01-20

Start date

Unknown

Completion date

Unknown

Last updated

2016-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief summary

This randomized, double-blind, placebo controlled, parallel and multiple dose study provided safety, preliminary efficacy, and immunogenicity information about the use of BMS-188667 and BMS-224818 in subjects with RA

Interventions

DRUGBelatacept

DRUGAbatacept

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Diagnosis of RA \< 5 years * Functional class I, II, or II as defined by the American College of Rheumatology (ACR) criteria. * Must have failed at least 1 Disease Modifying Anit-Rheumatic Drug (DMARD) * Joint count of 10 or more swollen and 12 or more tender. * Erythrocyte Sedimentation Rate (ESR) \> - 28mm/rr or norning stiffness \> - 45 minutes.

Exclusion criteria

* Women and men who are not willing to use an accepted form of contraception. * Active vasculitis * Treatment with another investigational drug within 30 days * History of asthma, angioedema, or anaphylaxix

Design outcomes

Primary

Measure	Time frame
Assess the relative safety and preliminary efficacy (clinical activity) of BMS-188667 and BMS-224818 in subjects with rheumatoid arthritis (RA)	—

Secondary

Measure	Time frame
Assess the immunogenicity of BMS-188667 and BMS-224818 in subjects with RA, and in a site specific substudy to the protocol, the pharmacokinetics (PK) and pharmacodynamics (PD) of BMS-188667 and BMS-224818 in subjects with RA	—

Countries

Belgium, Canada, France, Germany, Ireland, Netherlands, Switzerland, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026