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

Primary Purpose

Arthritis, Rheumatoid Arthritis

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

CDP6038

Placebo IV

Placebo SC

CDP 6038 SC

Methotrexate

About this trial

This is an interventional basic science trial for Arthritis focused on measuring CDP6038

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

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

1 mg/kg CDP6038 SC and Placebo SC

Optimized CDP6038 SC

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

Assess the immunogenicity of single dose CDP6038

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

Full Information

NCT ID

NCT01009242

First Posted

November 4, 2009

Last Updated

January 17, 2020

Sponsor

UCB Pharma

1. Study Identification

Unique Protocol Identification Number

NCT01009242

Brief Title

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

Official Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single Dose Evaluation of the Pharmacokinetics, Pharmacodynamics and Safety of IV and Subcutaneous CDP6038 in Subjects With Rheumatoid Arthritis on a Stable Dose of Methotrexate

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

October 2009 (Actual)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UCB Pharma

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

The secondary objectives of the study include determination of the absolute bioavailability of CDP6038 given via sc administration compared with iv infusion; assessment of the immunogenicity potential of single dose CDP6038 and assessment, on an exploratory basis, of other relevant systemic biomarkers and changes in clinical response.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arthritis, Rheumatoid Arthritis

Keywords

CDP6038

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

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

Arm Title

1 mg/kg CDP6038 SC and Placebo SC

Arm Type

Experimental

Arm Description

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

Arm Title

Optimized CDP6038 SC

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

CDP6038

Intervention Description

Single dose: 1 mg/kg CDP6038 IV

Intervention Type

Biological

Intervention Name(s)

CDP6038

Intervention Description

Single dose: 0.1mg/kg CDP6038 IV

Intervention Type

Biological

Intervention Name(s)

CDP6038

Intervention Description

Single dose: 1.0mg/kg CDP6038 SC

Intervention Type

Other

Intervention Name(s)

Placebo IV

Intervention Description

Single dose: Placebo IV

Intervention Type

Other

Intervention Name(s)

Placebo SC

Intervention Description

Single dose: Placebo SC

Intervention Type

Drug

Intervention Name(s)

CDP 6038 SC

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Methotrexate

Intervention Description

Individual stable doses of methotrexate.

Primary Outcome Measure Information:

Title

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

Time Frame

For 12 weeks following single dose

Title

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

Time Frame

For 12 weeks following single dose

Secondary Outcome Measure Information:

Title

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

Time Frame

For 12 weeks following single dose

Title

Assess the immunogenicity of single dose CDP6038

Time Frame

Multiple sampling from 0 to 12 weeks following single dose

Title

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

Time Frame

For 12 weeks following single dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

UCB Clinical Trial Call Center

Organizational Affiliation

+1 877 822 9493 (UCB)

Official's Role

Study Director

Facility Information:

City

Duncansville

State/Province

Pennsylvania

Country

United States

City

Dallas

State/Province

Texas

Country

United States

City

San Antonio

State/Province

Texas

Country

United States

City

Berlin

Country

Germany

City

Cologne

Country

Germany

City

Erlangen

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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