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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01202773




Registration number
NCT01202773
Ethics application status
Date submitted
14/09/2010
Date registered
16/09/2010
Date last updated
14/05/2018

Titles & IDs
Public title
A Study in Participants With Rheumatoid Arthritis
Scientific title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients With Moderate to Severe Rheumatoid Arthritis (RA) Who Had an Inadequate Response to One or More TNF-a Inhibitors (FLEX V)
Secondary ID [1] 0 0
H9B-MC-BCDV
Secondary ID [2] 0 0
13732
Universal Trial Number (UTN)
Trial acronym
FLEX V
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
Treatment: Drugs - Placebo Q4W
Treatment: Drugs - Placebo Q2W

Experimental: 120 milligrams (mg) LY2127399 - Given every 4 weeks (Q4W) for 24 weeks. Participants receive a 240-mg loading dose when initiating treatment.

During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks (Q2W).

At Week 16, responders will receive 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period.

At Week 16, non-responders (NR) will receive 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.

Experimental: 90 mg LY2127399 - Given Q2W for 24 weeks. Participants receive a 180-mg loading dose when initiating treatment.

At Week 16, both responders and NR will receive 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.

Placebo comparator: Placebo - Given Q2W for 24 weeks. Participants receive 2 injections of placebo when initiating treatment.

At Week 16, responders will receive 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.

At Week 16, NR will receive a 180-mg loading dose of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.


Treatment: Drugs: LY2127399
Administered Subcutaneously (SC)

Treatment: Drugs: Placebo Q4W
Administered SC

Treatment: Drugs: Placebo Q2W
Administered SC
Intervention code [1] 0 0
Treatment: Drugs
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
Baseline through Week 24
Secondary outcome [1] 0 0
Percentage of Participants With American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response
Timepoint [1] 0 0
Baseline through Week 24
Secondary outcome [2] 0 0
American College of Rheumatology Percent Improvement (ACR-N)
Timepoint [2] 0 0
Baseline through Week 24
Secondary outcome [3] 0 0
Change From Baseline to Week 24 in Tender Joint Count (68 Joint Count)
Timepoint [3] 0 0
Baseline, Week 24
Secondary outcome [4] 0 0
Change From Baseline to Week 24 in Swollen Joint Count (66 Joint Count)
Timepoint [4] 0 0
Baseline, Week 24
Secondary outcome [5] 0 0
Change From Baseline to Week 24 in Participant's Assessment of Pain [Visual Analog Scale (VAS)]
Timepoint [5] 0 0
Baseline, Week 24
Secondary outcome [6] 0 0
Change From Baseline to Week 24 in Participant's Global Assessment of Disease Activity (VAS)
Timepoint [6] 0 0
Baseline, Week 24
Secondary outcome [7] 0 0
Change From Baseline to Week 24 in Physician's Global Assessment of Disease Activity (VAS)
Timepoint [7] 0 0
Baseline, Week 24
Secondary outcome [8] 0 0
Change From Baseline to Week 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI)
Timepoint [8] 0 0
Baseline, Week 24
Secondary outcome [9] 0 0
Change From Baseline to Week 24 in Disease Activity Score Based on 28 Joint Count and C-Reactive Protein Level (DAS28-CRP)
Timepoint [9] 0 0
Baseline, Week 24
Secondary outcome [10] 0 0
Percentage of Participants With DAS28-CRP Based European League Against Rheumatism (EULAR) Response
Timepoint [10] 0 0
Baseline through Week 24
Secondary outcome [11] 0 0
Change From Baseline to Week 24 in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain and Summary Scores
Timepoint [11] 0 0
Baseline, Week 24
Secondary outcome [12] 0 0
Change From Baseline to Week 24 in Brief Fatigue Inventory (BFI) Individual Items and Impact Scores
Timepoint [12] 0 0
Baseline, Week 24
Secondary outcome [13] 0 0
Change From Baseline to Week 24 in Brief Pain Inventory Short Form (BPI-SF) Individual Items and Interference Scores
Timepoint [13] 0 0
Baseline, Week 24
Secondary outcome [14] 0 0
Change From Baseline to Week 24 in Duration of Morning Stiffness (Minutes)
Timepoint [14] 0 0
Baseline, Week 24
Secondary outcome [15] 0 0
Time to ACR20 Response
Timepoint [15] 0 0
Baseline through Week 24
Secondary outcome [16] 0 0
Change From Baseline to Week 24 in Absolute B Cell Counts
Timepoint [16] 0 0
Baseline, Week 24
Secondary outcome [17] 0 0
Change From Baseline to Week 24 in Serum Immunoglobulin (Ig) Levels
Timepoint [17] 0 0
Baseline, Week 24
Secondary outcome [18] 0 0
Population Pharmacokinetics (PK): Constant Clearance
Timepoint [18] 0 0
Baseline through Week 24
Secondary outcome [19] 0 0
Percentage of Participants Developing Anti-LY2127399 Antibodies
Timepoint [19] 0 0
Baseline through Week 24
Secondary outcome [20] 0 0
Change From Baseline to Week 24 in CRP
Timepoint [20] 0 0
Baseline, Week 24

Eligibility
Key inclusion criteria
* Diagnosis of RA of more than 6 months and less than 15 years
* At least 8 tender and swollen joints
* An abnormally high C-reactive protein (CRP) level or erythrocyte sedimentation rate (ESR)
* Positive for rheumatoid factor (RF) or anti-cyclic citrullinated peptide (CCP) antibody
* Previously treated with biologic TNF-a inhibitor therapy (infliximab, certolizumab, golimumab, etanercept, adalimumab) and stopped treatment due to insufficient efficacy or intolerance
* Regular use of at least 1 conventional disease-modifying anti-rheumatic drug (DMARD), with a stable dose for at least 8 weeks prior to study start
* 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
* Use of unstable doses of non-steroidal anti-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/day (mg/day) of oral steroids in the last 6 weeks
* 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 ago, 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 received 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
Stopped early
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
1/01/2014
Sample size
Target
Accrual to date
Final
456
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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United States of America
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01202773