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OpenTrials
Completed

NCT Number: NCT01009242

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

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.

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Key information

Conditions

Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Berlin, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CDP6038

Biological

Single dose:

1 mg/kg CDP6038 IV

Placebo IV

Other

Single dose:

Placebo IV

Placebo SC

Other

Single dose:

Placebo SC

CDP 6038 SC

Drug

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

methotrexate

Drug

Individual stable doses of methotrexate.

Primary outcomes

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

    Time frame: For 12 weeks following single dose

  2. 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 outcomes

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

    Time frame: For 12 weeks following single dose

  2. Assess the immunogenicity of single dose CDP6038

    Time frame: Multiple sampling from 0 to 12 weeks following single dose

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

    Time frame: For 12 weeks following single dose

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 6, 2009
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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