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To Evaluate the Blood Levels and Safety of IV and Subcutaneous CDP6038 in Subjects With Rheumatoid Arthritis Using Methotrexate

NCT01009242 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-11-15

No results posted yet for this study

Summary

The primary objectives are to determine the relationship between blood levels of CDP6038 and suppression of C-reactive Protein (CRP) following single doses given as intravenous (IV) infusion or subcutaneous (SC) injection to Rheumatoid Arthritis (RA) patients. The safety of CDP6038 will also be evaluated.

Conditions

Interventions

BIOLOGICAL

CDP6038

Single dose: 1 mg/kg CDP6038 IV

BIOLOGICAL

CDP6038

Single dose: 0.1mg/kg CDP6038 IV

BIOLOGICAL

CDP6038

Single dose: 1.0mg/kg CDP6038 SC

OTHER

Placebo IV

Single dose: Placebo IV

OTHER

Placebo SC

Single dose: Placebo SC

DRUG

CDP 6038 SC

Optimized CDP6038 SC doses based on outcome of Cohort 1 with placebo

DRUG

Methotrexate

Individual stable doses of methotrexate.

Sponsors & Collaborators

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

  • UCB Clinical Trial Call Center · +1 877 822 9493 (UCB)

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • United States
  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT01009242 on ClinicalTrials.gov