NCT01185353

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
301

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2010

Typical duration for phase_2

Geographic Reach
9 countries

68 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

April 21, 2017

Completed
Last Updated

June 16, 2017

Status Verified

May 1, 2017

Enrollment Period

1.2 years

First QC Date

August 18, 2010

Results QC Date

March 10, 2017

Last Update Submit

May 22, 2017

Conditions

Arthritis, Rheumatoid

Keywords

Rheumatoid ArthritisRA

Outcome Measures

Primary Outcomes (1)

  • 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

    ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time point are treated as non-responders. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) \* 100.

    Baseline through Week 12

Secondary Outcomes (32)

  • Percentage of Participants Who Achieved an ACR20 Responder Index Response Baseline Through Week 12 - Model Based Dose Response

    Baseline through Week 12

  • Percentage of Participants Who Achieved an ACR20 Responder Index Response Baseline Through Week 24

    Baseline through Weeks 2, 4, 8, 12, 16, 20, 24

  • Percentage of Participants Who Achieved an ACR20 Response Baseline Through Weeks 76 and 128

    Baseline through Weeks 76 and 128

  • Percentage of Participants Who Achieved an ACR 50 Responder Index Response Baseline Through Week 24

    Baseline through Weeks 2, 4, 8, 12, 16, 20, 24

  • Percentage of Participants Who Achieved an ACR50 Response Baseline Through Weeks 76 and 128

    Baseline through Weeks 76 and 128

  • +27 more secondary outcomes

Study Arms (6)

1 mg LY3009104 once daily

EXPERIMENTAL

Administered orally once daily for initial 12 weeks followed by randomization to either 4 mg LY3009104 once daily or 2 mg LY3009104 twice daily for an additional 12 weeks. After 24 weeks of treatment participants will be eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally once daily for 52 additional weeks. After 76 weeks of treatment participants will be eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally once daily for 52 additional weeks.

Drug: LY3009104Drug: Methotrexate

2 mg LY3009104 once daily

EXPERIMENTAL

Administered orally once daily for 24 weeks. After 24 weeks of treatment participants will be eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally once daily for 52 additional weeks. After 76 weeks of treatment participants will be eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally once daily for 52 additional weeks.

Drug: LY3009104Drug: Methotrexate

4 mg LY3009104 once daily

EXPERIMENTAL

Administered orally once daily for 24 weeks. After 24 weeks of treatment participants will be eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally once daily for 52 additional weeks. After 76 weeks of treatment participants will be eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally once daily for 52 additional weeks.

Drug: LY3009104Drug: Methotrexate

8 mg LY3009104 once daily

EXPERIMENTAL

Administered orally once daily for 24 weeks. After 24 weeks of treatment participants will be eligible to participate in an open-label extension period (Part C). Part C: 8 mg administered orally once daily for 52 additional weeks. After 76 weeks of treatment participants will be eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally once daily for 52 additional weeks.

Drug: LY3009104Drug: Methotrexate

Placebo once daily

PLACEBO COMPARATOR

Placebo administered orally once daily for initial 12 weeks followed by randomization to either 4 mg LY3009104 once daily or 2 mg LY3009104 twice daily for an additional 12 weeks. After 24 weeks of treatment participants will be eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally once daily for 52 additional weeks. After 76 weeks of treatment participants will be eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally once daily for 52 additional weeks.

Drug: PlaceboDrug: Methotrexate

2 mg LY3009104 twice daily

EXPERIMENTAL

(Not utilized in Part A) After 12 weeks treatment with 1 mg LY3009104 once daily or Placebo once daily in Part A, administered orally twice daily for 12 weeks. After 24 weeks of treatment participants will be eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally once daily for 52 additional weeks. After 76 weeks of treatment participants will be eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally once daily for 52 additional weeks.

Drug: LY3009104Drug: Methotrexate

Interventions

LY3009104DRUG

Administered orally

Also known as: Janus Kinase (JAK)1/JAK2 Inhibitor, JAK1/2 Inhibitor, INCB028050, baricitinib
1 mg LY3009104 once daily2 mg LY3009104 once daily2 mg LY3009104 twice daily4 mg LY3009104 once daily8 mg LY3009104 once daily
PlaceboDRUG

Administered orally

Placebo once daily
MethotrexateDRUG

Administered orally as background therapy

1 mg LY3009104 once daily2 mg LY3009104 once daily2 mg LY3009104 twice daily4 mg LY3009104 once daily8 mg LY3009104 once dailyPlacebo once daily

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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)

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (68)

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Paradise Valley, Arizona, 85253, United States

Location

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Peoria, Arizona, 85381, United States

Location

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Covina, California, 91723, United States

Location

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Santa Maria, California, 93454, United States

Location

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Westlake Village, California, 91361, United States

Location

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Aventura, Florida, 33180, United States

Location

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Boca Raton, Florida, 33432, United States

Location

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Daytona Beach, Florida, 32117, United States

Location

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Gainesville, Florida, 32607, United States

Location

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Jupiter, Florida, 33458, United States

Location

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Lake Mary, Florida, 32746, United States

Location

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Melbourne, Florida, 32901, United States

Location

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Naples, Florida, 34102, United States

Location

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Orlando, Florida, 32804, United States

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Palm Harbor, Florida, 34684, United States

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Vero Beach, Florida, 32960, United States

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South Bend, Indiana, 46601, United States

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Lexington, Kentucky, 40504, United States

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Columbia, Maryland, 21045, United States

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Flowood, Mississippi, 39216, United States

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St Louis, Missouri, 63117, United States

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Lincoln, Nebraska, 68516, United States

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Freehold, New Jersey, 07728, United States

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Toms River, New Jersey, 08755, United States

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Lake Success, New York, 11042, United States

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Middleburg Heights, Ohio, 44130, United States

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Toledo, Ohio, 43606, United States

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Oklahoma City, Oklahoma, 73103, United States

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Duncansville, Pennsylvania, 16635, United States

Location

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Dallas, Texas, 75231, United States

Location

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Houston, Texas, 77008, United States

Location

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Osijek, 31000, Croatia

Location

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Zagreb, 10000, Croatia

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Česká Lípa, 470 01, Czechia

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Hlučín, 748-01, Czechia

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Hostivice, 253-01, Czechia

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Hustopeče, 693 01, Czechia

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Prague, 128 50, Czechia

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Zlín, 760 01, Czechia

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Budapest, 1027, Hungary

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Debrecen, 4032, Hungary

Location

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Kistarcsa, 2143, Hungary

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Veszprém, 8200, Hungary

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Ahmedabad, 532004, India

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Hyderabaad, 500082, India

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Pune, 411007, India

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Trivandrum, 695011, India

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Cuauhtémoc, 06090, Mexico

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Guadalajara, 44158, Mexico

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León, 37000, Mexico

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Mexico City, Mexico

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San Luis Potosí City, 78200, Mexico

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Częstochowa, 42-200, Poland

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Elblag, 82-300, Poland

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Krakow, 30-349, Poland

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Poznan, 60-773, Poland

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Torun, 87-100, Poland

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Warsaw, 02-507, Poland

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Bacau, 600114, Romania

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Bucharest, 10584, Romania

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Cluj-Napoca, 400006, Romania

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Galati, 800587, Romania

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Iași, 700656, Romania

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Kiev, 03151, Ukraine

Location

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.

Kyiv, 01601, Ukraine

Location

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.

Simferopol, 95017, Ukraine

Location

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.

Ternopil, 46002, Ukraine

Location

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.

Vinnytsia, 21018, Ukraine

Location

Related Publications (6)

  • 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.

    PMID: 34706874DERIVED

  • 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.

    PMID: 30842122DERIVED

  • 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.

    PMID: 30647190DERIVED

  • 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.

    PMID: 29463520DERIVED

  • 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.

    PMID: 28811354DERIVED

  • 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.

    PMID: 25431052DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

baricitinibJanus KinasesMethotrexate

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Protein-Tyrosine KinasesProtein KinasesPhosphotransferases (Alcohol Group Acceptor)PhosphotransferasesTransferasesEnzymesEnzymes and CoenzymesIntracellular Signaling Peptides and ProteinsProteinsAmino Acids, Peptides, and ProteinsAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2010

First Posted

August 19, 2010

Study Start

October 1, 2010

Primary Completion

December 1, 2011

Study Completion

March 1, 2014

Last Updated

June 16, 2017

Results First Posted

April 21, 2017

Record last verified: 2017-05

Locations

IN(4)HU(4)PL(6)CZ(6)UA(5)ME(5)CR(2)RO(5)US(31)