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Trial record 1 of 1 for:    NCT01296711
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Open-label Study to Assess the Safety and Efficacy of CDP6038 in Patients Who Completed RA0056

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ClinicalTrials.gov Identifier: NCT01296711
Recruitment Status : Completed
First Posted : February 15, 2011
Last Update Posted : August 27, 2014
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )

Tracking Information
First Submitted Date  ICMJE February 14, 2011
First Posted Date  ICMJE February 15, 2011
Last Update Posted Date August 27, 2014
Study Start Date  ICMJE March 2011
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2011)
The occurrence of any adverse event. [ Time Frame: From baseline through end of study (up to 5 years) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2011)
  • Change from Baseline in the Disease Activity Score (C-reactive protein) [DAS28(CRP)] [ Time Frame: From baseline of the prior study (RA0056) to Week 12 ]
  • Change from Baseline in the Disease Activity Score (C-reactive protein) [DAS28(CRP)] [ Time Frame: From baseline of the prior study (RA0056) to Week 24 ]
  • Change from Baseline in the Disease Activity Score (C-reactive protein) [DAS28(CRP)] [ Time Frame: From baseline of the prior study (RA0056) to Week 48 ]
  • Change from Baseline in the Disease Activity Score (C-reactive protein) [DAS28(CRP)] [ Time Frame: From baseline of the prior study (RA0056) to Week 96 ]
  • American College of Rheumatology 20 (ACR20) response status [ Time Frame: From baseline of the prior study (RA0056) to Week 24 ]
  • American College of Rheumatology 20 (ACR20) response status [ Time Frame: From baseline of the prior study (RA0056) to Week 48 ]
  • American College of Rheumatology 50 (ACR50) response status [ Time Frame: From baseline of the prior study (RA0056) to Week 96 ]
  • American College of Rheumatology 70 (ACR70) response status [ Time Frame: From baseline of the prior study (RA0056) to Weeks 24, 48, and 96 ]
  • DAS28(CRP) <2.6 response status [ Time Frame: From baseline Baseline of the prior study (RA0056) to Week 12 ]
  • DAS28(CRP) <2.6 response status [ Time Frame: From baseline Baseline of the prior study (RA0056) to Week 24 ]
  • DAS28(CRP) <2.6 response status [ Time Frame: From baseline Baseline of the prior study (RA0056) to Week 48 ]
  • DAS28(CRP) <2.6 response status [ Time Frame: From baseline Baseline of the prior study (RA0056) to Week 96 ]
  • DAS28(CRP) <3.2 response status [ Time Frame: From baseline Baseline of the prior study (RA0056) to Week 12 ]
  • DAS28(CRP) <3.2 response status [ Time Frame: From baseline Baseline of the prior study (RA0056) to Week 24 ]
  • DAS28(CRP) <3.2 response status [ Time Frame: From baseline Baseline of the prior study (RA0056) to Week 48 ]
  • DAS28(CRP) <3.2 response status [ Time Frame: From baseline Baseline of the prior study (RA0056) to Week 96 ]
  • Change from Baseline in the Clinical Disease Activity Index (CDAI) [ Time Frame: From baseline of the prior study (RA0056) to Week 48 ]
  • Change from Baseline in the Clinical Disease Activity Index (CDAI) [ Time Frame: From baseline of the prior study (RA0056) to Week 96 ]
  • Change from Baseline in the Simplified Disease Activity Index (SDAI) [ Time Frame: From baseline of the prior study (RA0056) to Week 48 ]
  • Change from Baseline in the Simplified Disease Activity Index (SDAI) [ Time Frame: From baseline of the prior study (RA0056) to Week 96 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open-label Study to Assess the Safety and Efficacy of CDP6038 in Patients Who Completed RA0056
Official Title  ICMJE A Phase 2, Multicenter, Open-Label, Follow-up Study to Assess the Long-Term Safety and Efficacy of CDP6038 Administered Subcutaneously to Subjects With Active Rheumatoid Arthritis Who Completed Study RA0056
Brief Summary The purpose of this study is to evaluate the long term safety and tolerability of CDP6038 treatment in adult subjects with active rheumatoid arthritis (RA) who completed RA0056.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE Biological: CDP6038
100mg/ml solution for injection 120 mg subcutaneously (sc) every 2 weeks
Study Arms  ICMJE Experimental: CDP6038
Intervention: Biological: CDP6038
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 14, 2011)
190
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject completed the RA0056 study (Week 12 Visit)
  • Subject must have maintained their stable dose (and route) of methotrexate (MTX) between 12.5 to 25mg/week in RA0056, and plan to maintain this same dose and route of administration for at least 12 weeks
  • Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (either oral/parenteral/implantable hormonal contraceptives, intrauterine device, or barrier and spermicide). Abstinence is not considered an acceptable method of contraception for this study
  • Female subjects of childbearing potential must agree to use 2 methods of adequate contraception during the study and for 6 months (24 weeks) after their last CDP6038 dose
  • Male subjects must agree to ensure that they or their female partner(s) use adequate contraception during the study and for 12 weeks after the subject receives their last dose of CDP6038

Exclusion Criteria:

  • Subject has an ongoing serious adverse event from the RA0056 study
  • Female subject of childbearing potential has a positive pregnancy test or plans to become pregnant during the study or within 6 months (24 weeks) following their last dose of study medication
  • Subject has evidence of active or latent tuberculosis
  • Subject is receiving any biologic response modifier or synthetic disease-modifying antirheumatic drug other than MTX
  • Subject has an alcohol consumption of more than 1 unit per weekday. One unit equals 1 glass of beer or lager (~330mL), a glass of wine (125mL), or a measure of spirits/hard liquor (25mL)
  • Subject with any other condition in RA0056 (eg, clinically significant laboratory values, frequent adverse events) which in the Investigator's or Sponsor's judgment would make the subject unsuitable for inclusion in the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01296711
Other Study ID Numbers  ICMJE RA0057
2010-022224-77 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma ( UCB BIOSCIENCES, Inc. )
Study Sponsor  ICMJE UCB BIOSCIENCES, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
PRS Account UCB Pharma
Verification Date December 2013

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