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Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus

This study has been completed.
Sponsor:
Collaborator:
Biogen Idec
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT01764594
First received: January 2, 2013
Last updated: August 26, 2014
Last verified: August 2014

January 2, 2013
August 26, 2014
January 2013
August 2014   (final data collection date for primary outcome measure)
  • Percentage of subjects with at least one Treatment-emergent Adverse Event (TEAE) during the study [ Time Frame: 0 - 28 Weeks ] [ Designated as safety issue: No ]
  • Percentage of subjects who withdrew due to an Treatment-emergent Adverse Event (TEAE) during the study [ Time Frame: 0 - 28 Weeks ] [ Designated as safety issue: No ]
Incidence of Treatment-emergent Adervse Events (TEAE) in order to assess safety and tolerability of CDP7657 [ Time Frame: 0 to 12 Weeks ] [ Designated as safety issue: No ]
To assess the frequency and severity of TEAEs in patients receiving CDP7657 compared to those receiving placebo. This will include documentation of TEAE type, duration, causality, severity, outcome, action required and withdrawal rates.
Complete list of historical versions of study NCT01764594 on ClinicalTrials.gov Archive Site
  • Maximum plasma concentration (Cmax) [ Time Frame: 0 - 28 Weeks ] [ Designated as safety issue: No ]
  • Predose plasma concentration (Ctrough) [ Time Frame: 0 - 28 Weeks ] [ Designated as safety issue: No ]
  • Area under the concentration-time curve over the dosing interval (AUCτ) [ Time Frame: 0 - 28 Weeks ] [ Designated as safety issue: No ]
  • Maximum plasma concentration (Cmax) [ Time Frame: 0 - 12 Weeks ] [ Designated as safety issue: No ]
  • Predose plasma concentration (Ctrough) [ Time Frame: 0 - 12 Weeks ] [ Designated as safety issue: No ]
  • Area under the concentration-time curve over the dosing interval (AUCτ) [ Time Frame: 0 - 12 Weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus
A Multicenter, Investigator- and Subject-Blind, Randomized, Placebo-Controlled, Parallel-Group, Repeat-Dose Study to Evaluate the Effect of CDP7657 in Subjects With Active Systemic Lupus Erythematosus

To evaluate safety, tolerability pharmacokinetics and immunogenicity of CDP7657.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
  • Immune System Diseases
  • Autoimmune Diseases
  • Lupus Erythematosus, Systemic
  • Skin and Connective Tissue Diseases
  • Connective Tissue Disease
  • Biological: CDP7657

    CDP7657 100 mg/ ml solution

    30 mg/ kg initial dose

    15 mg/ kg every other week

    10 weeks

  • Other: Placebo
    Placebo comparator
  • Experimental: CDP7657

    CDP7657 100 mg/ ml solution

    30 mg/ kg initial dose

    15 mg/ kg every other week

    10 weeks

    Intervention: Biological: CDP7657
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
August 2014
August 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with Systemic Lupus Erythematosus (SLE)

Exclusion Criteria:

  • Severe neuropsychiatric or severe renal Systemic Lupus Erythematosus (SLE)
  • History of chronic, recurrent, or recent severe infection
  • Significant hematologic abnormalities
  • History of cancer, heart failure, renal disease, liver disease or other serious illness
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Bulgaria,   Germany,   Poland,   Romania,   Russian Federation,   Spain
 
NCT01764594
SL0014, 2012-000631-11
Yes
UCB Pharma
UCB Pharma
Biogen Idec
Study Director: UCB Clinical Trial Call Center +1 877 822 9493
UCB Pharma
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP