Clinical trial NCT01296711: Open-label Study to Assess the Safety and Efficacy of CDP6038 (Olokizumab) in Patients Who Completed RA0056
Official title: A Phase 2, Multicenter, Open-Label, Follow-up Study to Assess the Long-Term Safety and Efficacy of CDP6038 (Olokizumab) Administered Subcutaneously to Subjects With Active Rheumatoid Arthritis Who Completed Study RA0056
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
CDP6038
Interleukin-6
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
Collaborators: name: R-Pharm
First posted: 2011-02-15
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: RA0057 is a single arm study, however, analyses will also be performed according to the original treatment arms of the parent study RA0056 (NCT01242488).
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the long term safety and tolerability of CDP6038 (olokizumab) treatment in adult subjects with active rheumatoid arthritis who completed study RA0056 (NCT01242488).

Detailed description: Male and female subjects were randomized in a multi-center, open-label, follow-up study to assess the long-term safety and efficacy of a subcutaneous dose of 120 mg CDP6038 (olokizumab), every two weeks, for the treatment of active rheumatoid arthritis.

Eligibility 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 (olokizumab) 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 (olokizumab)

Exclusion Criteria:

* Subject has an ongoing serious adverse event from the RA0056 study
* Female subject of childbearing potential has a positive pregnancy test at Week 12 in Study RA0056 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

Primary outcomes:
measure: Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
timeFrame: From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Secondary outcomes:
measure: Change From Baseline (Week 0 of Study RA0056) in the Disease Activity Score-28-joint Count (C-reactive Protein) (DAS28[CRP]) to Week 12 of Study RA0057
timeFrame: Baseline (Week 0 of Study RA0056) and Week 12 (Study RA0057)
measure: Change From Baseline (Week 0 of Study RA0056) in DAS28(CRP) to Week 24 of Study RA0057
timeFrame: Baseline (Week 0 of Study RA0056) and Week 24 (Study RA0057)
measure: Change From Baseline (Week 0 of Study RA0056) in DAS28(CRP) to Week 48 of Study RA0057
timeFrame: Baseline (Week 0 of Study RA0056) and Week 48 (Study RA0057)
measure: Change From Baseline (Week 0 of Study RA0056) in DAS28(CRP) to Week 96 of Study RA0057
timeFrame: Baseline (Week 0 of Study RA0056) and Week 96 (Study RA0057)
measure: The American College of Rheumatology (ACR) 20% (ACR20) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 12 of Study RA0057
timeFrame: Baseline (Week 0 of Study RA0056) up to Week 12 (Study RA0057)
measure: The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 24 of Study RA0057
timeFrame: Baseline (Week 0 of Study RA0056) up to Week 24 (Study RA0057)
measure: The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 48 of Study RA0057
timeFrame: Baseline (Week 0 of Study RA0056) up to Week 48 (Study RA0057)
measure: The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 96 of Study RA0057
timeFrame: Baseline (Week 0 of Study RA0056) up to Week 96 (Study RA0057)
measure: The ACR 50% (ACR50) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 12 of Study RA0057
timeFrame: Baseline (Week 0 of Study RA0056) up to Week 12 (Study RA0057)
measure: The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 24 of Study RA0057
timeFrame: Baseline (Week 0 of Study RA0056) up to Week 24 (Study RA0057)
measure: The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 48 of Study RA0057
timeFrame: Baseline (Week 0 of Study RA0056) up to Week 48 (Study RA0057)
measure: The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 96 of Study RA0057
timeFrame: Baseline (Week 0 of Study RA0056) up to Week 96 (Study RA0057)
measure: The ACR 70% (ACR70) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 12 of Study RA0057
timeFrame: Baseline (Week 0 of Study RA0056) up to Week 12 (Study RA0057)
measure: The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 24 of Study RA0057
timeFrame: Baseline (Week 0 of Study RA0056) up to Week 24 (Study RA0057)
measure: The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 48 of Study RA0057
timeFrame: Baseline (Week 0 of Study RA0056) up to Week 48 (Study RA0057)
measure: The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 96 of Study RA0057
timeFrame: Baseline (Week 0 of Study RA0056) up to Week 96 (Study RA0057)
measure: Percentage of Subjects With DAS28(CRP) <2.6 at Week 12 of Study RA0057
timeFrame: Week 12 (Study RA0057)
measure: Percentage of Subjects With DAS28(CRP) <2.6 at Week 24 of Study RA0057
timeFrame: Week 24 (Study RA0057)
measure: Percentage of Subjects With DAS28(CRP) <2.6 at Week 48 of Study RA0057
timeFrame: Week 48 (Study RA0057)
measure: Percentage of Subjects With DAS28(CRP) <2.6 at Week 96 of Study RA0057
timeFrame: Week 96 (Study RA0057)
measure: Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 12 of Study RA0057
timeFrame: Week 12 (Study RA0057)
measure: Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 24 of Study RA0057
timeFrame: Week 24 (Study RA0057)
measure: Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 48 of Study RA0057
timeFrame: Week 48 (Study RA0057)
measure: Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 96 of Study RA0057
timeFrame: Week 96 (Study RA0057)
measure: Change From Baseline (Week 0 of Study RA0056) in the Clinical Disease Activity Index (CDAI) to Week 48 of Study RA0057
timeFrame: Baseline (Week 0 of Study RA0056) and Week 48 (Study RA0057)
measure: Change From Baseline (Week 0 of Study RA0056) in the CDAI to Week 96 of Study RA0057
timeFrame: Baseline (Week 0 of Study RA0056) and Week 96 (Study RA0057)
measure: Change From Baseline (Week 0 of Study RA0056) in the Simplified Disease Activity Index (SDAI) to Week 48 of Study RA0057
timeFrame: Baseline (Week 0 of Study RA0056) and Week 48 (Study RA0057)
measure: Change From Baseline (Week 0 of Study RA0056) in the SDAI to Week 96 of Study RA0057
timeFrame: Baseline (Week 0 of Study RA0056) and Week 96 (Study RA0057)
Other outcomes:
Locations:
city: Mesa
country: United States
facility: 166
state: Arizona
city: Phoenix
country: United States
facility: 154
state: Arizona
city: Scottsdale
country: United States
facility: 118
state: Arizona
city: Hot Springs
country: United States
facility: 103
state: Arkansas
city: Covina
country: United States
facility: 127
state: California
city: La Jolla
country: United States
facility: 148
state: California
city: Long Beach
country: United States
facility: 184
state: California
city: Los Angeles
country: United States
facility: 177
state: California
city: Palo Alto
country: United States
facility: 104
state: California
city: Santa Maria
country: United States
facility: 129
state: California
city: Upland
country: United States
facility: 164
state: California
city: Hamden
country: United States
facility: 141
state: Connecticut
city: Lewes
country: United States
facility: 111
state: Delaware
city: DeBary
country: United States
facility: 151
state: Florida
city: Jupiter
country: United States
facility: 114
state: Florida
city: Tampa
country: United States
facility: 157
state: Florida
city: Tampa
country: United States
facility: 183
state: Florida
city: Idaho Falls
country: United States
facility: 116
state: Idaho
city: Moline
country: United States
facility: 160
state: Illinois
city: Springfield
country: United States
facility: 168
state: Illinois
city: Cedar Rapids
country: United States
facility: 133
state: Iowa
city: Kansas City
country: United States
facility: 172
state: Kansas
city: Saint Clair Shores
country: United States
facility: 185
state: Michigan
city: Saint Louis
country: United States
facility: 112
state: Missouri
city: Saint Louis
country: United States
facility: 134
state: Missouri
city: Lincoln
country: United States
facility: 102
state: Nebraska
city: Freehold
country: United States
facility: 171
state: New Jersey
city: Toms River
country: United States
facility: 152
state: New Jersey
city: Brooklyn
country: United States
facility: 174
state: New York
city: Charlotte
country: United States
facility: 170
state: North Carolina
city: Cincinnati
country: United States
facility: 150
state: Ohio
city: Dayton
country: United States
facility: 100
state: Ohio
city: Oklahoma City
country: United States
facility: 110
state: Oklahoma
city: Duncansville
country: United States
facility: 165
state: Pennsylvania
city: Nashville
country: United States
facility: 105
state: Tennessee
city: Austin
country: United States
facility: 135
state: Texas
city: Dallas
country: United States
facility: 128
state: Texas
city: Houston
country: United States
facility: 126
state: Texas
city: Houston
country: United States
facility: 132
state: Texas
city: Houston
country: United States
facility: 138
state: Texas
city: Houston
country: United States
facility: 181
state: Texas
city: Mesquite
country: United States
facility: 145
state: Texas
city: Nassau Bay
country: United States
facility: 143
state: Texas
city: San Antonio
country: United States
facility: 122
state: Texas
city: Tomball
country: United States
facility: 144
state: Texas
city: Victoria
country: United States
facility: 142
state: Texas
city: Chesapeake
country: United States
facility: 139
state: Virginia
city: Tacoma
country: United States
facility: 175
state: Washington
city: Beckley
country: United States
facility: 136
state: West Virginia
city: Clarksburg
country: United States
facility: 167
state: West Virginia
city: Brussels
country: Belgium
facility: 401
city: Liege
country: Belgium
facility: 400
city: Essex
country: United Kingdom
facility: 206
city: Southampton
country: United Kingdom
facility: 208
city: Torquay
country: United Kingdom
facility: 209
Study officials:
affiliation: Stanford University
name: Mark Genovese, Dr
role: PRINCIPAL_INVESTIGATOR
References: