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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00837811




Registration number
NCT00837811
Ethics application status
Date submitted
3/02/2009
Date registered
5/02/2009
Date last updated
25/04/2018

Titles & IDs
Public title
An Open Label Extension Study in Participants With Rheumatoid Arthritis
Scientific title
An Open Label Extension Study of Multiple Subcutaneous Doses of LY2127399 in Patients With Rheumatoid Arthritis.
Secondary ID [1] 0 0
H9B-MC-BCDI
Secondary ID [2] 0 0
11768
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - LY2127399

Experimental: LY2127399 -


Treatment: Other: LY2127399
60 milligrams \[(mg) with potential for dose escalation to 120 mg\] subcutaneously every 4 weeks for 48 weeks
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52)
Primary outcome [2] 0 0
Number of Participants With Planned Laboratory Evaluations (Including Hematology, Clinical Chemistry, and Urinalysis) Reported as AEs
Timepoint [2] 0 0
Baseline through Week 112
Secondary outcome [1] 0 0
Change From Baseline in Tender Joint Count [Individual Component of the American College of Rheumatology (ACR) Core Set]
Timepoint [1] 0 0
Baseline, up to and through Week 52
Secondary outcome [2] 0 0
Change From Baseline in Swollen Joint Count (Individual Component of the ACR Core Set)
Timepoint [2] 0 0
Baseline, up to and through Week 52
Secondary outcome [3] 0 0
Change From Baseline in Participant's Assessment of Disease Activity (Individual Component of the ACR Core Set)
Timepoint [3] 0 0
Baseline, up to and through Week 52
Secondary outcome [4] 0 0
Change From Baseline in Physician's Global Assessment of Disease Activity (Individual Component of the ACR Core Set)
Timepoint [4] 0 0
Baseline, up to and through Week 52
Secondary outcome [5] 0 0
Change From Baseline in Health Assessment Questionnaire-Disability Index [(HAQ-DI) Individual Component of the ACR Core Set]
Timepoint [5] 0 0
Baseline, up to and through Week 52
Secondary outcome [6] 0 0
Change From Baseline in Participant's Assessment of Joint Pain (Individual Component of the ACR Core Set)
Timepoint [6] 0 0
Baseline, up to and through Week 52
Secondary outcome [7] 0 0
Percent Change From Baseline in C-Reactive Protein [(CRP) Individual Component of the ACR Core Set]
Timepoint [7] 0 0
Baseline, up to and through Week 52
Secondary outcome [8] 0 0
Percentage of Participants Achieving ACR20 Response
Timepoint [8] 0 0
Baseline, up to and through Week 52
Secondary outcome [9] 0 0
Percentage of Participants ACR50 Response
Timepoint [9] 0 0
Baseline, up to and through Week 52
Secondary outcome [10] 0 0
Percentage of Participants Achieving ACR70 Response
Timepoint [10] 0 0
Baseline, up to and through Week 52
Secondary outcome [11] 0 0
ACR-N Response
Timepoint [11] 0 0
Baseline, up to and through Week 52
Secondary outcome [12] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score
Timepoint [12] 0 0
Baseline, up to and through Week 52
Secondary outcome [13] 0 0
Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28)
Timepoint [13] 0 0
Baseline, up to and through Week 52
Secondary outcome [14] 0 0
Percentage of Participants With Response Based on European League Against Rheumatism Responder Index, 28 Joint Count (EULAR28)
Timepoint [14] 0 0
Baseline, up to and through Week 52
Secondary outcome [15] 0 0
Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Component Scores
Timepoint [15] 0 0
Baseline, up to and through Week 52
Secondary outcome [16] 0 0
Pharmacodynamics: Change From Baseline in Total B Cells [Cluster Designation 20+ (CD20+)] Absolute Cell Counts
Timepoint [16] 0 0
Baseline, Weeks 52, 60, 72, 80, 88, and 100
Secondary outcome [17] 0 0
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Timepoint [17] 0 0
Baseline, Weeks 52, 60, 72, 80, 88, and 100
Secondary outcome [18] 0 0
Pharmacodynamics: Change From Baseline in Serum Immunoglobulin
Timepoint [18] 0 0
Baseline, up to Week 52
Secondary outcome [19] 0 0
Pharmacodynamics: Change From Baseline in Rheumatoid Factor (RF) Levels at Week 52
Timepoint [19] 0 0
Baseline, Week 52
Secondary outcome [20] 0 0
Pharmacodynamics: Change From Baseline in Serum Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibodies
Timepoint [20] 0 0
Baseline, up to Week 52
Secondary outcome [21] 0 0
Pharmacodynamics: Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Timepoint [21] 0 0
Baseline, up to Week 52
Secondary outcome [22] 0 0
Number of Participants With LY2127399 Immunogenicity (Anti-LY2127399 Antibodies)
Timepoint [22] 0 0
Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post-study treatment follow-up (start of Week 53 or ED up to and through Week 112)

Eligibility
Key inclusion criteria
* Have given written informed consent
* Women must not be pregnant, breastfeeding or be at risk to become pregnant during study participation
* Have participated in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have had, during Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928), any safety event, [including having a recent, ongoing, or serious infection, a serious drug reaction, or any adverse event (AE) that caused discontinuation from treatment] that in the opinion of the investigator poses an unacceptable risk to participation in the study.
* Have received, during Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928), any drug not allowed by the study protocol including unapproved drugs, biologic disease-modifying anti-rheumatic drugs (DMARDs), or live vaccines.
* Enrollment in any other clinical trial involving off-label use of an investigational drug or device, or enrollment in any other type of medical research.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2012
Sample size
Target
Accrual to date
Final
182
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Elizabeth Vale
Recruitment postcode(s) [1] 0 0
5112 - Elizabeth Vale
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
South Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
Austria
State/province [13] 0 0
Vienna
Country [14] 0 0
Belgium
State/province [14] 0 0
Liege
Country [15] 0 0
Brazil
State/province [15] 0 0
Campinas
Country [16] 0 0
Brazil
State/province [16] 0 0
Curitiba
Country [17] 0 0
Brazil
State/province [17] 0 0
Goiania
Country [18] 0 0
Brazil
State/province [18] 0 0
Porto Alegre
Country [19] 0 0
Brazil
State/province [19] 0 0
Setor Oeste/Goiania
Country [20] 0 0
Canada
State/province [20] 0 0
Manitoba
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Chile
State/province [22] 0 0
Santiago
Country [23] 0 0
Chile
State/province [23] 0 0
Valdivia
Country [24] 0 0
Chile
State/province [24] 0 0
Vina Del Mar
Country [25] 0 0
Germany
State/province [25] 0 0
Hildesheim
Country [26] 0 0
Germany
State/province [26] 0 0
Leipzig
Country [27] 0 0
Hungary
State/province [27] 0 0
Budapest
Country [28] 0 0
Hungary
State/province [28] 0 0
Esztergom
Country [29] 0 0
Hungary
State/province [29] 0 0
Kistarcsa
Country [30] 0 0
Hungary
State/province [30] 0 0
Szolnok
Country [31] 0 0
India
State/province [31] 0 0
Lucknow
Country [32] 0 0
India
State/province [32] 0 0
Pune
Country [33] 0 0
India
State/province [33] 0 0
Secunderabad
Country [34] 0 0
Mexico
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Chihuahua
Country [35] 0 0
Mexico
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Cuernavaca
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Mexico
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Guadalajara
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Mexico
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Mexico City
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Mexico
State/province [38] 0 0
Monterrey
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Mexico
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San Luis Potosi
Country [40] 0 0
Mexico
State/province [40] 0 0
Tampico
Country [41] 0 0
Poland
State/province [41] 0 0
Bialystok
Country [42] 0 0
Poland
State/province [42] 0 0
Chelm Slaski
Country [43] 0 0
Poland
State/province [43] 0 0
Elblag
Country [44] 0 0
Poland
State/province [44] 0 0
Krakow
Country [45] 0 0
Poland
State/province [45] 0 0
Lubin
Country [46] 0 0
Poland
State/province [46] 0 0
Lublin
Country [47] 0 0
Poland
State/province [47] 0 0
Poznan
Country [48] 0 0
Poland
State/province [48] 0 0
Torun
Country [49] 0 0
Poland
State/province [49] 0 0
Warsaw
Country [50] 0 0
Poland
State/province [50] 0 0
Wroclaw
Country [51] 0 0
Puerto Rico
State/province [51] 0 0
San Juan
Country [52] 0 0
Romania
State/province [52] 0 0
Brasov
Country [53] 0 0
Romania
State/province [53] 0 0
Targu-Mures

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To evaluate the safety and tolerability of LY2127399 administered as subcutaneous injections for 48 weeks in participants with Rheumatoid Arthritis
Trial website
https://clinicaltrials.gov/study/NCT00837811
Trial related presentations / publications
Greenwald M, Szczepanski L, Kennedy A, Veenhuizen M, Komocsar WJ, Polasek E, Guerrettaz K, Berclaz PY, Lee C. A 52-week, open-label study evaluating the safety and efficacy of tabalumab, an anti-B-cell-activating factor monoclonal antibody, for rheumatoid arthritis. Arthritis Res Ther. 2014 Aug 29;16(4):415. doi: 10.1186/s13075-014-0415-2.
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UCT/GMT-5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00837811