NCT01009242

Brief 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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2009

Geographic Reach
2 countries

6 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

October 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

November 15, 2024

Status Verified

November 1, 2024

Enrollment Period

11 months

First QC Date

November 4, 2009

Last Update Submit

November 12, 2024

Conditions

ArthritisRheumatoid Arthritis

Keywords

CDP6038

Outcome Measures

Primary Outcomes (2)

  • PK/PD relationship between systemic CDP6038 exposure and CRP suppression.

    For 12 weeks following single dose

  • Evaluate the safety and tolerability of single doses of CDP6038 For 12 weeks following single dose

    For 12 weeks following single dose

Secondary Outcomes (3)

  • Absolute bioavailability of CDP6038 given by sc injection in comparison with iv infusion

    For 12 weeks following single dose

  • Assess the immunogenicity of single dose CDP6038

    Multiple sampling from 0 to 12 weeks following single dose

  • Assess, on an exploratory basis, changes in clinical response and other systemic biomarkers associated with RA

    For 12 weeks following single dose

Study Arms (3)

0.1mg/kg and 1mg/kg CDP6038 IV and Placebo IV

EXPERIMENTAL

Cohort 1, Group 1 will compare 0.1mg/kg, 1mg/kg CDP6038 and placebo IV.

Biological: CDP6038Other: Placebo IVDrug: Methotrexate

1 mg/kg CDP6038 SC and Placebo SC

EXPERIMENTAL

Cohort 1, Group 2 will compare 1mg/kg CDP6038 and placebo sc.

Biological: CDP6038Other: Placebo SCDrug: Methotrexate

Optimized CDP6038 SC

EXPERIMENTAL

Cohort 2, Group 3 will compare optimized sc doses of CDP6038 based on outcome of Cohort 1 with placebo.

Drug: CDP 6038 SCDrug: Methotrexate

Interventions

CDP6038BIOLOGICAL

Single dose: 1 mg/kg CDP6038 IV

0.1mg/kg and 1mg/kg CDP6038 IV and Placebo IV
Placebo IVOTHER

Single dose: Placebo IV

0.1mg/kg and 1mg/kg CDP6038 IV and Placebo IV
Placebo SCOTHER

Single dose: Placebo SC

1 mg/kg CDP6038 SC and Placebo SC
CDP 6038 SCDRUG

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

Optimized CDP6038 SC
MethotrexateDRUG

Individual stable doses of methotrexate.

0.1mg/kg and 1mg/kg CDP6038 IV and Placebo IV1 mg/kg CDP6038 SC and Placebo SCOptimized CDP6038 SC

Eligibility Criteria

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

You may qualify if:

  • RA \> 6 months duration on stable Methotrexate
  • ≤9 swollen and ≤9 tender joints (28 joint count)
  • Minimum Screening CRP of 0.5mg/L

You may not qualify if:

  • Participation in previous studies with defined agents and durations
  • Previous treatment with defined agents and durations
  • Presence of, or history of defined medical conditions including those particularly associated with deficiency in immune response
  • Pregnancy
  • Positive tests/signs of possible latent/active tuberculosis
  • Positive HIV
  • Drug addiction or alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Duncansville, Pennsylvania, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Cologne, Germany

Location

Unknown Facility

Erlangen, Germany

Location

MeSH Terms

Conditions

ArthritisArthritis, Rheumatoid

Interventions

olokizumabMethotrexate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • UCB Clinical Trial Call Center

    +1 877 822 9493 (UCB)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2009

First Posted

November 6, 2009

Study Start

October 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

November 15, 2024

Record last verified: 2024-11

Locations

DE(3)US(3)