Clinical trial NCT01185353: A Study in Participants With Rheumatoid Arthritis on Background Methotrexate Therapy
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group, Phase 2b Study of LY3009104 in Patients With Active Rheumatoid Arthritis on Background Methotrexate Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arthritis, Rheumatoid
Keywords: Rheumatoid Arthritis
RA
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Incyte Corporation
First posted: 2010-08-19
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to evaluate the safety and efficacy of LY3009104 in participants with Rheumatoid Arthritis (RA).

Detailed description: This study consists of the following:

* Screening period: 4 to 28-days
* Part A: a 12-week blinded, placebo controlled treatment period
* Part B: a 12-week blinded extension period
* Part C: an optional 52-week open-label extension period
* Part D: an additional optional 52-week open-label extension period
* Follow up period: 28 days

Eligibility criteria: Inclusion Criteria:

* Must have active RA
* Must regularly use methotrexate (MTX) for at least 12 weeks before your participation in this study
* Must have American College of Rheumatology (ACR) functional class I, II, or III
* Must have C-reactive protein (CRP) measurement \> 1.2 times upper limit of normal (ULN) or Erythrocyte Sedimentation Rate (ESR) \> ULN \[28 millimeters/hour (mm/hr)\]
* Have laboratory values that in the opinion of the investigator do not pose an unacceptable risk to the participants if study drug would be administered
* Must have venous access sufficient to allow blood sampling as per the protocol
* Must be reliable and willing to be available for the duration of the study and are willing to follow study procedures
* Must be able to read, understand, and give written informed consent approved by Lilly or its designee and the ethical review board (ERB) governing the site
* Male participants: agree to use 2 forms of highly effective methods of birth control with female partners of childbearing potential during the study
* If you are a woman and you could become pregnant during this study, you must talk to the study doctor about birth control. You are required to use 2 forms of highly effective methods of birth control to avoid getting pregnant during the study
* If you are a post-menopausal woman, you must be at least 45 years of age and have not menstruated for the last 12 months
* If you are a woman between 40 and 45 years of age, test negative for pregnancy, and have not menstruated during the last 12 months only, you must have an additional blood test
* For participants receiving corticosteroids, you must be on a dose not to exceed 10 mg of prednisone daily (or equivalent) and have been on the same dosing regimen for at least 6 weeks prior to randomization
* Continue to meet inclusion criteria for Parts A and B as applicable
* Part D only: have completed the 52 weeks (Week 24 to Week 76) of participation in Part C of the study without permanent study drug discontinuation and have not completed the Follow-Up Visit (approximately 28 days after the last dose of study drug)

Exclusion Criteria:

* Must not have received any parenteral corticosteroid administered by intra-articular, intramuscular (IM), or intravenous (IV) injection within 6 weeks prior to baseline
* Must not be concomitantly using non-steroidal anti-inflammatory drugs (NSAIDS), unless you are on a stable dose within the last 4 weeks
* Must not have received any prior biologic disease modifying anti-rheumatic drug (DMARD) therapy \[such as Tumor necrosis factor-alpha (TNFα), interleukin (IL)-1, IL-6, T-cell or B-cell target therapies)
* Must not have used DMARDs other than methotrexate (MTX), hydroxychloroquine, or sulfasalazine within the last 8 weeks
* Must not have used leflunomide within the last 12 weeks and have not received cholestyramine to speed up the elimination of leflunomide from your body
* Must not have previously been randomized, completed or withdrawn from this study or any other study investigating LY3009104
* Must not have received prior treatment with an oral JAK inhibitor
* Must not have a current or recent (within the last 30 days) viral, bacterial, fungal, or parasitic infection
* Must not have had a serious infection (for example, pneumonia, cellulitis, or bone or joint infections) or atypical mycobacterial infection within the last 6 months
* Must not have had symptomatic herpes zoster or herpes simplex infection within the last 90 days or have a history of disseminated/complicated herpes zoster
* Must not have evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies
* Must not have evidence of hepatitis C virus (HCV) or active hepatitis B
* Must not have evidence or suspicion of active or latent tuberculosis (TB)
* Must not have another serious disorder or illness
* Must not be exposed to a live vaccine within the last 12 weeks
* Must not have donated more than 500 milliliters (mL) of blood within the last month
* Must not have had surgery on a joint that is to be assessed in the study within the last 2 months, or will require such during the study
* Must not be currently enrolled in, or discontinued within the last 30 days from a clinical trial involving an investigational drug or device or off-label use of a drug, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
* Presence of significant uncontrolled cerebro-cardiovascular \[for example (eg), myocardial infarction (MI), unstable angina (UA), unstable arterial hypertension, severe heart failure or cerebrovascular accident\], respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematologic or neuropsychiatric disorders, or abnormal laboratory values that in the opinion of the investigator pose an unacceptable risk to the participant if study drug would be administered

Primary outcomes:
measure: Percentage of Participants in the 4 mg and 8 mg Dose Groups Who Achieved an American College of Rheumatology 20 (ACR20) Responder Index Response Baseline Through Week 12
timeFrame: Baseline through Week 12
Secondary outcomes:
measure: Percentage of Participants Who Achieved an ACR20 Responder Index Response Baseline Through Week 12 - Model Based Dose Response
timeFrame: Baseline through Week 12
measure: Percentage of Participants Who Achieved an ACR20 Responder Index Response Baseline Through Week 24
timeFrame: Baseline through Weeks 2, 4, 8, 12, 16, 20, 24
measure: Percentage of Participants Who Achieved an ACR20 Response Baseline Through Weeks 76 and 128
timeFrame: Baseline through Weeks 76 and 128
measure: Percentage of Participants Who Achieved an ACR 50 Responder Index Response Baseline Through Week 24
timeFrame: Baseline through Weeks 2, 4, 8, 12, 16, 20, 24
measure: Percentage of Participants Who Achieved an ACR50 Response Baseline Through Weeks 76 and 128
timeFrame: Baseline through Weeks 76 and 128
measure: Percentage of Participants Who Achieved an ACR70 Responder Index Response Baseline Through Week 24
timeFrame: Baseline through Weeks 2, 4, 8, 12, 16, 20, 24
measure: Percentage of Participants Who Achieved an ACR70 Response Baseline Through Weeks 76 and 128
timeFrame: Baseline through Weeks 76 and 128
measure: Percentage of Participants Who Achieved an ACR50 Response Baseline Through Week 12 - Model Based Dose Response
timeFrame: Baseline through Week 12
measure: ACR Percent Improvement (ACR-N)
timeFrame: Baseline through Week 12
measure: Mean Change From Baseline to Weeks 12 and 24 in Tender and Swollen Joint Counts (TJC and SJC)
timeFrame: Baseline, Weeks 12 and 24
measure: Mean Change From Baseline to Weeks 76 and 128 in TJC and SJC
timeFrame: Baseline, Weeks 76 and 128
measure: Mean Change From Baseline to Weeks 12 and 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
timeFrame: Baseline, Weeks 12 and 24
measure: Mean Change From Baseline to Weeks 76 and 128 in HAQ-DI Score
timeFrame: Baseline, Weeks 76 and 128
measure: Mean Change From Baseline to Weeks 12 and 24 in High-Sensitivity C-Reactive Protein (hsCRP)
timeFrame: Baseline, Weeks 12 and 24
measure: Mean Change From Baseline to Weeks 76 and 128 in hsCRP
timeFrame: Baseline, Weeks 76 and 128
measure: Mean Change From Baseline to Weeks 12 and 24 in Erythrocyte Sedimentation Rate (ESR)
timeFrame: Baseline, Weeks 12 and 24
measure: Mean Change From Baseline to Weeks 76 and 128 in ESR
timeFrame: Baseline, Weeks 76 and 128
measure: Mean Change From Baseline to Weeks 12 and 24 in Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity and Patient's Assessment of Pain
timeFrame: Baseline, Weeks 12 and 24
measure: Mean Change From Baseline to Weeks 76 and 128 in Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity and Patient's Assessment of Pain
timeFrame: Baseline, Weeks 76 and 128
measure: Mean Change From Baseline to Weeks 12 and 24 in Disease Activity Score (DAS) Based on the 28 Diarthrodial Joint Count and CRP Level (DAS28-CRP)
timeFrame: Baseline, Weeks 12 and 24
measure: Mean Change From Baseline to Weeks 76 and 128 in DAS28-CRP
timeFrame: Baseline, Weeks 76 and 128
measure: Percentage of Responders According to European League Against Rheumatism Responder Index Based on 28-joint Count (EULAR28) Baseline Through Weeks 12 and 24
timeFrame: Baseline through Weeks 12 and 24
measure: Percentage of Responders According to EULAR28 Baseline Through Weeks 76 and 128
timeFrame: Baseline, Weeks 76 and 128
measure: Percentage of Participants Meeting Low Disease Activity and Remission Based on the 28 Diarthrodial Joint Count (DAS28) Baseline Through Weeks 12 and 24
timeFrame: Baseline through Weeks 12 and 24
measure: Percentage of Participants Meeting Low Disease Activity and Remission Based on the 28 Diarthrodial Joint Count (DAS28) Baseline Through Weeks 76 and 128
timeFrame: Baseline through Weeks 76 and 128
measure: Mean Change From Baseline Through Week 12 in Duration (Minutes) of Morning Stiffness
timeFrame: Baseline, Weeks 4, 8, 12
measure: Mean Change From Baseline to Week 12 in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores
timeFrame: Baseline, Week 12
measure: Mean Change From Baseline to Week 12 in Brief Pain Inventory Modified Short Form (BPI-sf Modified) Worst-Pain-in-the Past-24-hours Item Score
timeFrame: Baseline, Week 12
measure: Mean Change From Baseline to Week 12 in Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) Score
timeFrame: Baseline, Week 12
measure: Population Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of LY3009104
timeFrame: Baseline through 24 weeks
measure: Population PK: Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau,ss) of LY3009104
timeFrame: Baseline through 24 weeks
measure: Mean Change From Baseline Through Week 12 in the ENSEMBLE Minimum Data Set 1.0
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Paradise Valley
country: United States
facility: 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.
state: Arizona
city: Peoria
country: United States
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state: Arizona
city: Covina
country: United States
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state: California
city: Santa Maria
country: United States
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state: California
city: Westlake Village
country: United States
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state: California
city: Aventura
country: United States
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state: Florida
city: Boca Raton
country: United States
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state: Florida
city: Daytona Beach
country: United States
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state: Florida
city: Gainesville
country: United States
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state: Florida
city: Jupiter
country: United States
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state: Florida
city: Lake Mary
country: United States
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state: Florida
city: Melbourne
country: United States
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state: Florida
city: Naples
country: United States
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state: Florida
city: Orlando
country: United States
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state: Florida
city: Palm Harbor
country: United States
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state: Florida
city: Vero Beach
country: United States
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state: Florida
city: South Bend
country: United States
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state: Indiana
city: Lexington
country: United States
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state: Kentucky
city: Columbia
country: United States
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state: Maryland
city: Flowood
country: United States
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state: Mississippi
city: Saint Louis
country: United States
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state: Missouri
city: Lincoln
country: United States
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state: Nebraska
city: Freehold
country: United States
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state: New Jersey
city: Toms River
country: United States
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state: New Jersey
city: Lake Success
country: United States
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state: New York
city: Middleburg Heights
country: United States
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state: Ohio
city: Toledo
country: United States
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state: Ohio
city: Oklahoma City
country: United States
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state: Oklahoma
city: Duncansville
country: United States
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state: Pennsylvania
city: Dallas
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: Osijek
country: Croatia
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city: Zagreb
country: Croatia
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city: Ceska Lipa
country: Czechia
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city: Hlucin
country: Czechia
facility: 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.
city: Hostivice
country: Czechia
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city: Hustopece
country: Czechia
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city: Prague
country: Czechia
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city: Zlin
country: Czechia
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city: Budapest
country: Hungary
facility: 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.
city: Debrecen
country: Hungary
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city: Kistarcsa
country: Hungary
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city: Veszprem
country: Hungary
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city: Ahmedabad
country: India
facility: 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.
city: Hyderabaad
country: India
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city: Pune
country: India
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city: Trivandrum
country: India
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city: Cuauhtemoc
country: Mexico
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city: Guadalajara
country: Mexico
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city: Leon
country: Mexico
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city: Mexico City
country: Mexico
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city: San Luis Potosi
country: Mexico
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city: Czestochowa
country: Poland
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city: Elblag
country: Poland
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city: Krakow
country: Poland
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city: Poznan
country: Poland
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city: Torun
country: Poland
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city: Warsaw
country: Poland
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city: Bacau
country: Romania
facility: 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.
city: Bucharest
country: Romania
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city: Cluj-Napoca
country: Romania
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city: Galati
country: Romania
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city: Iasi
country: Romania
facility: 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.
city: Kiev
country: Ukraine
facility: 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.
city: Kyiv
country: Ukraine
facility: 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.
city: Simferopol
country: Ukraine
facility: 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.
city: Ternopil
country: Ukraine
facility: 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.
city: Vinnytsya
country: Ukraine
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: Taylor PC, Takeuchi T, Burmester GR, Durez P, Smolen JS, Deberdt W, Issa M, Terres JR, Bello N, Winthrop KL. Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database. Ann Rheum Dis. 2022 Mar;81(3):335-343. doi: 10.1136/annrheumdis-2021-221276. Epub 2021 Oct 27.
citation: Combe B, Balsa A, Sarzi-Puttini P, Tony HP, de la Torre I, Rogai V, Durand F, Witt S, Zhong J, Dougados M. Efficacy and safety data based on historical or pre-existing conditions at baseline for patients with active rheumatoid arthritis who were treated with baricitinib. Ann Rheum Dis. 2019 Aug;78(8):1135-1138. doi: 10.1136/annrheumdis-2018-214261. Epub 2019 Mar 6. No abstract available.
citation: Peterfy C, DiCarlo J, Emery P, Genovese MC, Keystone EC, Taylor PC, Schlichting DE, Beattie SD, Luchi M, Macias W. MRI and Dose Selection in a Phase II Trial of Baricitinib with Conventional Synthetic Disease-modifying Antirheumatic Drugs in Rheumatoid Arthritis. J Rheumatol. 2019 Aug;46(8):887-895. doi: 10.3899/jrheum.171469. Epub 2019 Jan 15.
citation: Taylor PC, Kremer JM, Emery P, Zuckerman SH, Ruotolo G, Zhong J, Chen L, Witt S, Saifan C, Kurzawa M, Otvos JD, Connelly MA, Macias WL, Schlichting DE, Rooney TP, de Bono S, McInnes IB. Lipid profile and effect of statin treatment in pooled phase II and phase III baricitinib studies. Ann Rheum Dis. 2018 Jul;77(7):988-995. doi: 10.1136/annrheumdis-2017-212461. Epub 2018 Feb 20.
citation: Keystone EC, Genovese MC, Schlichting DE, de la Torre I, Beattie SD, Rooney TP, Taylor PC. Safety and Efficacy of Baricitinib Through 128 Weeks in an Open-label, Longterm Extension Study in Patients with Rheumatoid Arthritis. J Rheumatol. 2018 Jan;45(1):14-21. doi: 10.3899/jrheum.161161. Epub 2017 Aug 15.
citation: Keystone EC, Taylor PC, Drescher E, Schlichting DE, Beattie SD, Berclaz PY, Lee CH, Fidelus-Gort RK, Luchi ME, Rooney TP, Macias WL, Genovese MC. Safety and efficacy of baricitinib at 24 weeks in patients with rheumatoid arthritis who have had an inadequate response to methotrexate. Ann Rheum Dis. 2015 Feb;74(2):333-40. doi: 10.1136/annrheumdis-2014-206478. Epub 2014 Nov 27.