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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01202760




Registration number
NCT01202760
Ethics application status
Date submitted
14/09/2010
Date registered
16/09/2010
Date last updated
25/04/2018

Titles & IDs
Public title
A Rheumatoid Arthritis Study in Participants
Scientific title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA) With or Without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX O)
Secondary ID [1] 0 0
H9B-MC-BCDO
Secondary ID [2] 0 0
12978
Universal Trial Number (UTN)
Trial acronym
FLEX O
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
Experimental: 120 mg LY2127399 - LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240-mg (2 SC injections of 120 mg each) loading dose of LY2127399 when initiating treatment.

During the Treatment Period, for blinding purposes, participants alternated injections of LY2127399 and injections of Placebo every 2 weeks.

After 16 weeks, non-responders received 90 mg of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.

Experimental: 90 mg LY2127399 - LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180-mg (2 SC injections of 90 mg each) loading dose of LY2127399 when initiating treatment.

After 16 weeks, non-responders continued to receive 90 mg of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.

Placebo comparator: Placebo - Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections of Placebo when initiating treatment.

After 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With American College of Rheumatology 20% (ACR20) Response
Timepoint [1] 0 0
Up to 24 weeks
Secondary outcome [1] 0 0
Percentage of Participants With American College of Rheumatology 50% (ACR50) and 70% (ACR70) Responses
Timepoint [1] 0 0
Up to 24 weeks
Secondary outcome [2] 0 0
Mean Percent Improvement in American College of Rheumatology Percent Improvement (ACR-N)
Timepoint [2] 0 0
Up to 24 weeks
Secondary outcome [3] 0 0
Change From Baseline to 24 Weeks in Tender Joint Count (68 Joint Count)
Timepoint [3] 0 0
Baseline, up to 24 weeks
Secondary outcome [4] 0 0
Change From Baseline to 24 Weeks in Swollen Joint Count (66 Joint Count)
Timepoint [4] 0 0
Baseline, up to 24 weeks
Secondary outcome [5] 0 0
Change From Baseline to 24 Weeks in Participant's Assessment of Pain (Visual Analog Scale)
Timepoint [5] 0 0
Baseline, up to 24 weeks
Secondary outcome [6] 0 0
Change From Baseline to 24 Weeks in Participant's Global Assessment of Disease Activity (Visual Analog Scale)
Timepoint [6] 0 0
Baseline, up to 24 weeks
Secondary outcome [7] 0 0
Change From Baseline to 24 Weeks in Physician's Global Assessment of Disease Activity (Visual Analog Scale)
Timepoint [7] 0 0
Baseline, up to 24 weeks
Secondary outcome [8] 0 0
Change From Baseline to 24 Weeks in Disease Activity Score (Based on 28 Joint Count)-C-Reactive Protein (DAS28-CRP)
Timepoint [8] 0 0
Baseline, up to 24 weeks
Secondary outcome [9] 0 0
Change From Baseline to 24 Weeks in Health Assessment Questionnaire-Disability Index (HAQ-DI)
Timepoint [9] 0 0
Baseline, up to 24 weeks
Secondary outcome [10] 0 0
Time to American College of Rheumatology 20% (ACR20) Response
Timepoint [10] 0 0
Baseline through 24 weeks
Secondary outcome [11] 0 0
Probability of an ACR20 Response by 24 Weeks
Timepoint [11] 0 0
Baseline through 24 weeks
Secondary outcome [12] 0 0
Percentage of Participants With DAS28-Based European League Against Rheumatism (EULAR) Response
Timepoint [12] 0 0
Up to 24 weeks
Secondary outcome [13] 0 0
Change From Baseline to 24 Weeks in Medical Outcomes Study 36-Item Short Form (SF-36) Health Status Survey Domain and Summary Scores
Timepoint [13] 0 0
Baseline, up to 24 weeks
Secondary outcome [14] 0 0
Change From Baseline in C-reactive Protein (CRP) up to Week 24 Endpoint
Timepoint [14] 0 0
Baseline, up to 24 weeks
Secondary outcome [15] 0 0
Change From Baseline to 24 Weeks in Absolute CD3-CD20+ B-cell Counts
Timepoint [15] 0 0
Baseline, up to 24 weeks
Secondary outcome [16] 0 0
Change From Baseline to 24 Weeks in Serum Immunoglobulin (Ig) Levels
Timepoint [16] 0 0
Baseline, up to 24 weeks
Secondary outcome [17] 0 0
Population Pharmacokinetics (PK)
Timepoint [17] 0 0
Baseline through 24 weeks
Secondary outcome [18] 0 0
Percentage of Participants Developing Anti-LY2127399 Antibodies
Timepoint [18] 0 0
Baseline through 24 weeks

Eligibility
Key inclusion criteria
* Diagnosis of Rheumatoid Arthritis (RA) of more than 6 months and less than 15 years
* Global Assessment of Disease Activity visual analog scale (VAS) greater than or equal to 20/100 millimeters (mm)
* If on one or more conventional disease-modifying anti-rheumatic Drugs (DMARDs) at randomization, must have been on a stable dose for at least 8 weeks prior to study start.
* Women 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
* Use of unstable doses of non-steroidal inflammatory drugs (NSAIDS) in the past 6 weeks
* Steroid injection or intravenous (IV) infusion in the last 6 weeks
* Use of more than 10 milligrams per day (mg/day) of oral steroids in the last 6 weeks
* Use of biologic DMARD concurrently or recently
* History of a serious reaction to other biological DMARDs
* Use of an oral calcineurin inhibitor (for example, cyclosporin or tacrolimus) in the last 8 weeks
* Surgery on a joint or other major surgery less than 2 months prior to study start, or plans to have joint surgery or major surgery during the study
* Active fibromyalgia, juvenile chronic arthritis, spondyloarthropathy, Crohn's disease, ulcerative colitis, psoriatic arthritis, or other systemic inflammatory condition except RA
* Cervical cancer or squamous skin cancer within the past 3 years, or other cancer within the past 5 years
* Received a live vaccine within the past 12 weeks (for example, vaccines for measles, mumps, rubella, and chicken pox, and nasal-spray flu vaccines)
* Hepatitis or human immunodeficiency virus (HIV)
* A serious bacterial infection (for example, pneumonia or cellulitis) within 3 months or a serious bone or joint infection within 6 months
* Symptoms of herpes zoster or herpes simplex within the last month
* Active or latent tuberculosis (TB)
* Current symptoms of a serious disorder or illness
* Use of an investigational drug within the last month

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
1/01/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2013
Sample size
Target
Accrual to date
Final
1004
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. - Kogarah
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. - Herston
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. - Malvern East
Recruitment postcode(s) [1] 0 0
04266-010 - Kogarah
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
3145 - Malvern East
Recruitment outside Australia
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Durban
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Pretoria
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Sri Lanka
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Colombo
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Galle
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Sri Lanka
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Sri Lanka
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Nugegoda
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Taiwan
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Keelong
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Kuei Shan Hsiang
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Taichung
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Taipei
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Ukraine
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Dnipropetrovsk
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Donetsk
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Kharkiv
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Kiev
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Ukraine
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Kyiv
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Ukraine
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Odesa
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Ukraine
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Poltava
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Simferopol
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Ukraine
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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 in the treatment of rheumatoid arthritis with or without background disease-modifying anti-rheumatic drug (DMARD) therapy.

This study is comprised of 2 periods:

Period 1 - 24-week blinded treatment

Period 2 - 48-week post-treatment follow-up
Trial website
https://clinicaltrials.gov/study/NCT01202760
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 9 AM - 5 PM Eastern time (UTC/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/NCT01202760