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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01198002




Registration number
NCT01198002
Ethics application status
Date submitted
8/09/2010
Date registered
9/09/2010
Date last updated
8/05/2018

Titles & IDs
Public title
A Rheumatoid Arthritis Study in Participants on a Background Treatment of Methotrexate
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 Methotrexate Therapy (FLEX M)
Secondary ID [1] 0 0
H9B-MC-BCDM
Secondary ID [2] 0 0
11352
Universal Trial Number (UTN)
Trial acronym
FLEX M
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 Q2W
Treatment: Drugs - Placebo Q4W
Treatment: Drugs - Methotrexate

Experimental: 120 milligrams (mg) LY2127399 - Given every 4 weeks (Q4W) for 100 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 Weeks 16 and 52, 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 100-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 100-week treatment period.

Experimental: 90 mg LY2127399 - Given Q2W for 100 weeks. Participants receive a 180 mg loading dose when initiating treatment.

At Weeks 16 and 52, responders will receive 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q4W for the rest of the 100-week treatment period.

At Week 16, 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 100-week treatment period.

Placebo comparator: Placebo - Given Q2W for 52 weeks. At Week 16, responders will receive 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 52 weeks.

At Week 52, responders are randomized to receive 1 of the 2 doses of LY2127399, with loading dose of 240 mg or 180 mg of LY2127399, followed by 120 mg of LY2127399 Q4W or 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.

At Week 16, NR will receive a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.


Treatment: Drugs: LY2127399
Administered Subcutaneously (SC)

Treatment: Drugs: Placebo Q2W
Administered SC

Treatment: Drugs: Placebo Q4W
Administered SC

Treatment: Drugs: Methotrexate
Methotrexate is a background therapy.
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% Response (ACR20) at Week 24
Timepoint [1] 0 0
Baseline through 24 weeks
Primary outcome [2] 0 0
Change From Baseline to Week 52 in Van Der Heijde Modified Total Sharp Score (mTSS)
Timepoint [2] 0 0
Baseline, 52 Weeks
Primary outcome [3] 0 0
Change From Baseline to Week 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI)
Timepoint [3] 0 0
Baseline, 24 weeks
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 24 weeks and 52 weeks
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, 24 weeks and 52 weeks
Secondary outcome [3] 0 0
Percentage of Participants With DAS28-CRP Based European League Against Rheumatism (EULAR) Response
Timepoint [3] 0 0
Baseline through 24 weeks and 52 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, 24 weeks and 52 weeks
Secondary outcome [5] 0 0
Change From Baseline in Brief Fatigue Inventory (BFI) Individual Items and Impact Score
Timepoint [5] 0 0
Baseline, 24 weeks and 52 weeks
Secondary outcome [6] 0 0
Change From Baseline in Duration of Morning Stiffness (Minutes)
Timepoint [6] 0 0
Baseline, 24 weeks and 52 weeks
Secondary outcome [7] 0 0
Change From Baseline in Brief Pain Inventory Short Form (BPI-SF) Individual Items and Interference Scores
Timepoint [7] 0 0
Baseline, 24 weeks and 52 weeks
Secondary outcome [8] 0 0
Percentage of Participants With Major Clinical Response (MCR) During 52 Weeks
Timepoint [8] 0 0
Baseline through 52 weeks
Secondary outcome [9] 0 0
Percentage of Participants With Change From Baseline in mTSS Less Than or Equal to (=) 0
Timepoint [9] 0 0
Baseline through 24 weeks
Secondary outcome [10] 0 0
Change From Baseline to Week 52 in B Cell Subset Counts
Timepoint [10] 0 0
Baseline, 52 weeks
Secondary outcome [11] 0 0
Population Pharmacokinetics (PK): Constant Clearance
Timepoint [11] 0 0
Baseline through 52 weeks
Secondary outcome [12] 0 0
Percentage of Participants Developing Anti-LY2127399 Antibodies
Timepoint [12] 0 0
Baseline through 52 weeks
Secondary outcome [13] 0 0
Percentage of Participants With No Structural Progression at Week 52
Timepoint [13] 0 0
Baseline through 52 weeks
Secondary outcome [14] 0 0
Change From Baseline to Week 24 in mTSS
Timepoint [14] 0 0
Baseline, 24 weeks
Secondary outcome [15] 0 0
Change From Baseline in Serum Immunoglobulin (Ig) Levels
Timepoint [15] 0 0
Baseline, 52 weeks
Secondary outcome [16] 0 0
Change From Baseline in Joint Space Narrowing Score and Bone Erosions Score (Components of mTSS)
Timepoint [16] 0 0
Baseline, 24 weeks and 52 weeks
Secondary outcome [17] 0 0
American College of Rheumatology Percent Improvement (ACR-N)
Timepoint [17] 0 0
Baseline through 24 weeks and 52 weeks
Secondary outcome [18] 0 0
Change From Baseline in Tender Joint Count (68 Joint Count)
Timepoint [18] 0 0
Baseline, 24 weeks and 52 weeks
Secondary outcome [19] 0 0
Change From Baseline in Swollen Joint Count (66 Joint Count)
Timepoint [19] 0 0
Baseline, 24 weeks and 52 weeks
Secondary outcome [20] 0 0
Change From Baseline in Participant's Assessment of Pain [Visual Analog Scale (VAS)]
Timepoint [20] 0 0
Baseline, 24 weeks and 52 weeks
Secondary outcome [21] 0 0
Change From Baseline in Participant's Global Assessment of Disease Activity (VAS)
Timepoint [21] 0 0
Baseline, 24 weeks and 52 weeks
Secondary outcome [22] 0 0
Change From Baseline in Physician's Global Assessment of Disease Activity (VAS)
Timepoint [22] 0 0
Baseline, 24 weeks and 52 weeks
Secondary outcome [23] 0 0
Change From Baseline to Week 52 in HAQ-DI
Timepoint [23] 0 0
Baseline, 52 weeks
Secondary outcome [24] 0 0
Change From Baseline to Week 52 in Absolute B Cell Counts
Timepoint [24] 0 0
Baseline, 52 weeks
Secondary outcome [25] 0 0
Percentage of Participants With ACR20 at Week 52
Timepoint [25] 0 0
Baseline through 52 weeks
Secondary outcome [26] 0 0
Time to ACR20 Response
Timepoint [26] 0 0
Baseline through 52 weeks
Secondary outcome [27] 0 0
Change From Baseline in CRP
Timepoint [27] 0 0
Baseline, 24 weeks and 52 weeks

Eligibility
Key inclusion criteria
* Diagnosis of Rheumatoid Arthritis (RA) of more than 6 months and less than 15 years
* Regular use of methotrexate (MTX) in the past 12 weeks, with the dose being stable during the past 8 weeks
* At least 8 tender and swollen joints
* At least one erosion of a hand or foot joint observed on an X-ray
* 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
* 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 an inadequate response to a biologic disease-modifying anti-rheumatic drug (DMARD)
* History of a serious reaction to other biological DMARDs
* History of the use of rituximab or other B cell therapy
* Use of DMARDS other than MTX, hydroxychloroquine, or sulfasalazine within the last 8 weeks
* Use of leflunomide within the last 12 weeks (unless cholestyramine was used to speed up the elimination of leflunomide)
* 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
* History of the use of rituximab, any other B cell targeted biotherapy, or denosumab

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 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
1/12/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2014
Sample size
Target
Accrual to date
Final
1041
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. - 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
2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
3145 - Malvern East
Recruitment outside Australia
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Dunajska Streda
Country [162] 0 0
Slovakia
State/province [162] 0 0
Piestany
Country [163] 0 0
South Africa
State/province [163] 0 0
Benoni
Country [164] 0 0
South Africa
State/province [164] 0 0
Bloemfontein
Country [165] 0 0
South Africa
State/province [165] 0 0
Cape Town
Country [166] 0 0
South Africa
State/province [166] 0 0
Durban
Country [167] 0 0
South Africa
State/province [167] 0 0
Limpopo
Country [168] 0 0
South Africa
State/province [168] 0 0
Pretoria
Country [169] 0 0
South Africa
State/province [169] 0 0
Somerset West
Country [170] 0 0
South Africa
State/province [170] 0 0
Stellenbosch
Country [171] 0 0
Sri Lanka
State/province [171] 0 0
Colombo
Country [172] 0 0
Sri Lanka
State/province [172] 0 0
Galle
Country [173] 0 0
Sri Lanka
State/province [173] 0 0
Kalubowila
Country [174] 0 0
Sri Lanka
State/province [174] 0 0
Nugegoda
Country [175] 0 0
Taiwan
State/province [175] 0 0
Chiayi
Country [176] 0 0
Taiwan
State/province [176] 0 0
Keelung
Country [177] 0 0
Taiwan
State/province [177] 0 0
Kuei Shan Hsiang
Country [178] 0 0
Taiwan
State/province [178] 0 0
Niao Sung Hsiang
Country [179] 0 0
Taiwan
State/province [179] 0 0
Taichung
Country [180] 0 0
Taiwan
State/province [180] 0 0
Taipei
Country [181] 0 0
Ukraine
State/province [181] 0 0
Dnipropetrovsk
Country [182] 0 0
Ukraine
State/province [182] 0 0
Donetsk
Country [183] 0 0
Ukraine
State/province [183] 0 0
Kharkiv
Country [184] 0 0
Ukraine
State/province [184] 0 0
Kyiv
Country [185] 0 0
Ukraine
State/province [185] 0 0
Odesa
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Poltava
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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 while on a background treatment of methotrexate.

This study is comprised of 3 periods:

Period 1: 52-week blinded treatment

Period 2: additional 48-week unblinded treatment

Period 3: 48-week post-treatment follow-up
Trial website
https://clinicaltrials.gov/study/NCT01198002
Trial related presentations / publications
Smolen JS, Weinblatt ME, van der Heijde D, Rigby WF, van Vollenhoven R, Bingham CO 3rd, Veenhuizen M, Gill A, Zhao F, Komocsar WJ, Berclaz PY, Ortmann R, Lee C. Efficacy and safety of tabalumab, an anti-B-cell-activating factor monoclonal antibody, in patients with rheumatoid arthritis who had an inadequate response to methotrexate therapy: results from a phase III multicentre, randomised, double-blind study. Ann Rheum Dis. 2015 Aug;74(8):1567-70. doi: 10.1136/annrheumdis-2014-207090. Epub 2015 Apr 14.
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/NCT01198002