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, Inc. ( UCB BIOSCIENCES, Inc. )
ClinicalTrials.gov Identifier:
NCT01296711
First received: February 14, 2011
Last updated: December 12, 2013
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, Inc.:

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

  Hide Study Locations
Locations
United States, Arizona
166
Mesa, Arizona, United States
154
Phoenix, Arizona, United States
118
Scottsdale, Arizona, United States
United States, Arkansas
103
Hot Springs, Arkansas, United States
United States, California
127
Covina, California, United States
148
La Jolla, California, United States
184
Long Beach, California, United States
177
Los Angeles, California, United States
104
Palo Alto, California, United States
129
Santa Maria, California, United States
164
Upland, California, United States
United States, Connecticut
141
Hamden, Connecticut, United States
United States, Delaware
111
Lewes, Delaware, United States
United States, Florida
151
Debary, Florida, United States
114
Jupiter, Florida, United States
157
Tampa, Florida, United States
183
Tampa, Florida, United States
United States, Idaho
116
Idaho Falls, Idaho, United States
United States, Illinois
160
Moline, Illinois, United States
168
Springfield, Illinois, United States
United States, Iowa
133
Cedar Rapids, Iowa, United States
United States, Kansas
172
Kansas City, Kansas, United States
United States, Michigan
185
St. Clair Shores, Michigan, United States
United States, Missouri
134
St Louis, Missouri, United States
112
St. Louis, Missouri, United States
United States, Nebraska
102
Lincoln, Nebraska, United States
United States, New Jersey
171
Freehold, New Jersey, United States
152
Toms River, New Jersey, United States
United States, New York
174
Brooklyn, New York, United States
United States, North Carolina
170
Charlotte, North Carolina, United States
United States, Ohio
150
Cincinnati, Ohio, United States
100
Dayton, Ohio, United States
United States, Oklahoma
110
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
165
Duncansville, Pennsylvania, United States
United States, Tennessee
105
Nashville, Tennessee, United States
United States, Texas
135
Austin, Texas, United States
128
Dallas, Texas, United States
126
Houston, Texas, United States
132
Houston, Texas, United States
138
Houston, Texas, United States
181
Houston, Texas, United States
145
Mesquite, Texas, United States
143
Nassau Bay, Texas, United States
122
San Antonio, Texas, United States
144
Tomball, Texas, United States
142
Victoria, Texas, United States
United States, Virginia
139
Chesapeake, Virginia, United States
United States, Washington
175
Tacoma, Washington, United States
United States, West Virginia
136
Beckley, West Virginia, United States
167
Clarksburg, West Virginia, United States
Belgium
401
Brussels, Belgium
400
Liege, Belgium
United Kingdom
206
Essex, United Kingdom
208
Southampton, United Kingdom
209
Torquay, United Kingdom
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, Inc. ( UCB BIOSCIENCES, Inc. )
ClinicalTrials.gov Identifier: NCT01296711     History of Changes
Other Study ID Numbers: RA0057
Study First Received: February 14, 2011
Last Updated: December 12, 2013
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, Inc.:
Rheumatoid arthritis
CDP6038
Interleukin-6

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

ClinicalTrials.gov processed this record on July 31, 2014