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Open-label Study to Assess the Safety and Efficacy of CDP6038 in Patients Who Completed RA0056

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )
ClinicalTrials.gov Identifier:
NCT01296711
First received: February 14, 2011
Last updated: August 26, 2014
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Biological: CDP6038
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • The occurrence of any adverse event. [ Time Frame: From baseline through end of study (up to 5 years) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • American College of Rheumatology 20 (ACR20) response status [ Time Frame: From baseline of the prior study (RA0056) to Week 24 ] [ Designated as safety issue: No ]
  • American College of Rheumatology 20 (ACR20) response status [ Time Frame: From baseline of the prior study (RA0056) to Week 48 ] [ Designated as safety issue: No ]
  • American College of Rheumatology 50 (ACR50) response status [ Time Frame: From baseline of the prior study (RA0056) to Week 96 ] [ Designated as safety issue: No ]
  • American College of Rheumatology 70 (ACR70) response status [ Time Frame: From baseline of the prior study (RA0056) to Weeks 24, 48, and 96 ] [ Designated as safety issue: No ]
  • DAS28(CRP) <2.6 response status [ Time Frame: From baseline Baseline of the prior study (RA0056) to Week 12 ] [ Designated as safety issue: No ]
  • DAS28(CRP) <2.6 response status [ Time Frame: From baseline Baseline of the prior study (RA0056) to Week 24 ] [ Designated as safety issue: No ]
  • DAS28(CRP) <2.6 response status [ Time Frame: From baseline Baseline of the prior study (RA0056) to Week 48 ] [ Designated as safety issue: No ]
  • DAS28(CRP) <2.6 response status [ Time Frame: From baseline Baseline of the prior study (RA0056) to Week 96 ] [ Designated as safety issue: No ]
  • DAS28(CRP) <3.2 response status [ Time Frame: From baseline Baseline of the prior study (RA0056) to Week 12 ] [ Designated as safety issue: No ]
  • DAS28(CRP) <3.2 response status [ Time Frame: From baseline Baseline of the prior study (RA0056) to Week 24 ] [ Designated as safety issue: No ]
  • DAS28(CRP) <3.2 response status [ Time Frame: From baseline Baseline of the prior study (RA0056) to Week 48 ] [ Designated as safety issue: No ]
  • DAS28(CRP) <3.2 response status [ Time Frame: From baseline Baseline of the prior study (RA0056) to Week 96 ] [ Designated as safety issue: No ]
  • Change from Baseline in the Clinical Disease Activity Index (CDAI) [ Time Frame: From baseline of the prior study (RA0056) to Week 48 ] [ Designated as safety issue: No ]
  • Change from Baseline in the Clinical Disease Activity Index (CDAI) [ Time Frame: From baseline of the prior study (RA0056) to Week 96 ] [ Designated as safety issue: No ]
  • Change from Baseline in the Simplified Disease Activity Index (SDAI) [ Time Frame: From baseline of the prior study (RA0056) to Week 48 ] [ Designated as safety issue: No ]
  • Change from Baseline in the Simplified Disease Activity Index (SDAI) [ Time Frame: From baseline of the prior study (RA0056) to Week 96 ] [ Designated as safety issue: No ]

Enrollment: 190
Study Start Date: March 2011
Study Completion Date: August 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CDP6038 Biological: CDP6038
100mg/ml solution for injection 120 mg subcutaneously (sc) every 2 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01296711

  Show 55 Study Locations
Sponsors and Collaborators
UCB BIOSCIENCES, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB Pharma ( UCB BIOSCIENCES, Inc. )
ClinicalTrials.gov Identifier: NCT01296711     History of Changes
Other Study ID Numbers: RA0057, 2010-022224-77
Study First Received: February 14, 2011
Last Updated: August 26, 2014
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by UCB Pharma:
Rheumatoid arthritis
CDP6038
Interleukin-6

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 20, 2014