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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01215942




Registration number
NCT01215942
Ethics application status
Date submitted
5/10/2010
Date registered
7/10/2010
Date last updated
11/06/2018

Titles & IDs
Public title
An Open Label Study for Participants With Rheumatoid Arthritis
Scientific title
A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA)
Secondary ID [1] 0 0
H9B-MC-BCDP
Secondary ID [2] 0 0
13419
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: Drugs - LY2127399

Experimental: 120 milligrams (mg) of LY2127399 - Given every 4 weeks for 240 weeks for those participants from Study BCDO or Study BCDV. Participants who had been receiving placebo immediately prior to enrollment will receive a 240 mg loading dose when initiating treatment.

Or

Given every 4 weeks for 168 weeks for those participants from Study BCDM.

Experimental: 90 mg LY2127399 - Given every 2 weeks for 240 weeks for those participants from Study BCDO or Study BCDV. Participants who had been receiving placebo immediately prior to enrollment will receive a 180 mg loading dose when initiating treatment.

Or

Given every 2 weeks for 168 weeks for those participants from Study BCDM.


Treatment: Drugs: LY2127399
Administered Subcutaneously
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESI)During Treatment Period
Timepoint [1] 0 0
up to 84.4 weeks during treatment period
Primary outcome [2] 0 0
Percentage of Participants Developing Anti-LY2127399 Antibodies
Timepoint [2] 0 0
Baseline through Weeks 4, 24, 48 and 72
Primary outcome [3] 0 0
Change From Baseline in Absolute B Cell Counts
Timepoint [3] 0 0
Baseline, Week 48
Primary outcome [4] 0 0
Change From Baseline in Serum Immunoglobulin (Ig) Levels
Timepoint [4] 0 0
Baseline, Week 48
Secondary outcome [1] 0 0
Percentage of Participants With American College of Rheumatology 20% Response (ACR20)
Timepoint [1] 0 0
Baseline through Weeks 12, 24 and 48
Secondary outcome [2] 0 0
Change From Baseline in Disease Activity Score Based on 28 Joint Count and C-Reactive Protein Level (DAS28-CRP)
Timepoint [2] 0 0
Baseline, 240 weeks
Secondary outcome [3] 0 0
Percentage of Participants With DAS28-Based European League Against Rheumatism (EULAR-28) Response
Timepoint [3] 0 0
Baseline through 240 weeks
Secondary outcome [4] 0 0
Change From Baseline in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain Scores and Summary Scores
Timepoint [4] 0 0
Baseline, 240 weeks
Secondary outcome [5] 0 0
Change From Baseline in Tender Joint Count (68 Joint Count)
Timepoint [5] 0 0
Baseline, 240 weeks
Secondary outcome [6] 0 0
Change From Baseline in Swollen Joint Count (66 Joint Count)
Timepoint [6] 0 0
Baseline, 240 weeks
Secondary outcome [7] 0 0
Change From Baseline in Participant's Assessment of Pain [Visual Analog Scale (VAS)]
Timepoint [7] 0 0
Baseline, 240 weeks
Secondary outcome [8] 0 0
Change From Baseline in Participants Global Assessment of Disease Activity (VAS)
Timepoint [8] 0 0
Baseline, 240 weeks
Secondary outcome [9] 0 0
Change From Baseline in Physicians Global Assessment of Disease Activity (VAS)
Timepoint [9] 0 0
Baseline, 240 weeks
Secondary outcome [10] 0 0
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
Timepoint [10] 0 0
Baseline, 240 weeks
Secondary outcome [11] 0 0
Change From Baseline in CRP
Timepoint [11] 0 0
Baseline, 240 weeks
Secondary outcome [12] 0 0
American College of Rheumatology Percent Improvement (ACR-N)
Timepoint [12] 0 0
Baseline through 240 weeks

Eligibility
Key inclusion criteria
* Have completed 24 weeks of participation in Study H9B-MC-BCDO or Study H9B-MC-BCDV, or have completed 100 weeks of participation in Study H9B-MC-BCDM
* Woman must not be pregnant, breastfeeding, or become pregnant during the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Current presence of a serious disorder or illness

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2014
Sample size
Target
Accrual to date
Final
1086
Recruitment in Australia
Recruitment state(s)
NSW,QLD
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. - Campbelltown
Recruitment hospital [2] 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. - Kogarah
Recruitment hospital [3] 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. - Herston
Recruitment hospital [4] 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. - Malvern East
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
04266-010 - Kogarah
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
3145 - Malvern East
Recruitment outside Australia
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Stellenbosch
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Spain
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Bilboa
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Spain
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La Coruña
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Spain
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Madrid
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San Sebastian
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Colombo
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Galle
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Sri Lanka
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Kalubowila
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Nugegoda
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Keelung
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Kuei Shan Hsiang
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Taichung
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Dnipropetrovsk
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Donetsk
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Kharkiv
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Kiev
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Kyiv
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Odesa
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Poltava
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Vinnytsya

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

Ethics approval
Ethics application status

Summary
Brief summary
The primary purpose of this study is to help answer if LY2127399 is safe and effective during long-term treatment in participants with Rheumatoid Arthritis.

This study is comprised of 2 periods:

Period 1: Unblinded treatment for up to 240 weeks for participants who enroll from Study H9B-MC-BCDO (BCDO) (NCT01202760) or Study H9B-MC-BCDV (BCDV) (NCT01202773) or up to 168 weeks for participants who enroll from Study H9B-MC-BCDM (BCDM) (NCT01198002).

Period 2: 48-week post-treatment follow-up
Trial website
https://clinicaltrials.gov/study/NCT01215942
Trial related presentations / publications
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/NCT01215942