Rheumatoid ArthritisPhase 2NCT00966875
A Study in Patients With Rheumatoid Arthritis
A Phase 2 study testing LY2439821 in people with Rheumatoid Arthritis, run by Eli Lilly and Company at 75 sites in 11 countries.
Trial summary
The primary purpose of the study is to help answer the following research questions, and not to provide treatment for Rheumatoid Arthritis (RA): The safety of LY2439821 and any side effects that might be associated with it. Whether LY2439821 can help participants with active RA. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- LY2439821
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 448 participants
- Where
- 75 sitesin 11 countries
- Study dates
- Aug 2009to Jun 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- You must be between the ages of 18 and 75
- You must have active RA
- Qualifications Specific to the bDMARD-naive Population:
- You must be regularly using methotrexate (MTX) for at least 12 weeks before your participation in this study
- Qualifications Specific to the TNFα-IR Population:
- You must have been treated with at least 1 biologic TNFα inhibitor therapy and either had an insufficient response to at least 3 months of treatment OR have been intolerant of such treatment
- You must be regularly using at least 1 conventional DMARD in a stable treatment regimen
Who cannot join
- You are concomitantly using non-steroidal anti-inflammatory drugs (NSAIDS), unless you are on a stable dose within the last 2 weeks
- You are a woman who is lactating or breast feeding
- You have donated more than 300 milliliters (mL) of blood within the last month
- You have received glucocorticoid administered by intra-articular, intramuscular, or intravenous injection or oral corticosteroids at an average daily dose of greater than 10 mg per day of prednisone or its equivalent within the last 4 weeks
- You had surgery on a joint that is to be assessed in the study within 2 months of study enrollment, or will require such during the study
- You have another serious disorder or illness
Show all 24Show fewer
- You suffered a serious bacterial infection (for example, pneumonia, cellulitis, or bone or joint infections) within the last 3 months
- You have a history of uncontrolled high blood pressure
- You have clinical laboratory test results at entry that are outside the normal reference range
- You are an employee of the clinic or you are an immediate family member of an employee of the clinic. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
- You are currently participating in or were discontinued within the last 30 days from another clinical trial involving an investigational drug
- If you are a woman and you could become pregnant during this study, you must talk to the study doctor about the birth control that you will use 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 post-menopausal 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 to see if you can participate.
- If you are male, you must agree to reduce the risk of your female partner becoming pregnant during the study.
- Exclusions Specific to the bDMARD-naive Population:
- You have received any prior bDMARD therapy such as TNFα, Interleukin (IL)-1, IL-6, T-cell, or B-cell targeted therapies
- You have had an inadequate response to a minimum of 3 months of treatment with 5 or more conventional DMARDs [such as leflunomide, azathioprine, cyclosporine, etcetera (etc.)]
- You have used DMARDs other than MTX, hydroxychloroquine, or sulfasalazine within the last 8 weeks
- You have used leflunomide within the last 12 weeks and have not received cholestyramine to speed up the elimination of leflunomide from your body.
- Exclusions Specific to the TNFα-IR Population:
- You are currently using or recently used a bDMARD or a biologic TNFα inhibitor therapy within specified periods
- You have had a serious reaction to other biologic DMARDs that, in the study doctor's opinion, puts you at serious risk
- You have used cyclosporine or any other immunosuppressive in the 8 weeks before your participation in this study
Trial locations and contacts
75 sites in 11 countries.
75 sites in 11 countries
United States37 sites
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Arlington, Virginia, 22205
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Bethlehem, Pennsylvania, 18017
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Bingham Farms, Michigan, 48025
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Charleston, South Carolina, 29407
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Cumberland, Maryland, 21502
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Decatur, Georgia, 30329
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Denver, Colorado, 80230
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Frederick, Maryland, 21702
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Idaho Falls, Idaho, 83404
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La Mesa, California, 91942
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Lake Mary, Florida, 32746
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Melbourne, Florida, 32901
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Memphis, Tennessee, 38119
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Milwaukee, Wisconsin, 53217
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Olympia, Washington, 98502
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Palm Desert, California, 92260
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Peoria, Arizona, 85381
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Rome, Georgia, 30165
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Salt Lake City, Utah, 84143
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San Jose, California, 95126
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Santa Maria, California, 93454
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Sarasota, Florida, 34239
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Sellersville, Pennsylvania, 18960
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Spokane, Washington, 99202
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Springfield, Illinois, 62704
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St Louis, Missouri, 63117
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St. Petersburg, Florida, 33710
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Stanford, California, 94305
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Sugar Land, Texas, 77479
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Tampa, Florida, 33614
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Temple, Texas, 76508
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Tulsa, Oklahoma, 74135
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Vero Beach, Florida, 32962
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Washington D.C., District of Columbia, 20003
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Westlake Village, California, 91361
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Wheaton, Maryland, 20902
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Wilmington, North Carolina, 28401
Poland8 sites
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Bytom, 41-902
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Częstochowa, 42-200
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Gmina Końskie, 26-200
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Kościan, 64-000
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Krakow, 30-510
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Poznan, 60-773
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Torun, 87-100
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Warsaw, 02-507
Taiwan5 sites
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Kaohsiung County, 833
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Taichung, 40201
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Taichung, 404
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Taipei, 100
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Taoyuan, 333
Argentina4 sites
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Buenos Aires, C1425AWC
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Quilmes, B1878DVC
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San Juan, 05400
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San Miguel de Tucumán, 4000
Germany4 sites
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Freiburg im Breisgau, 79106
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Hamburg, 22415
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Hohenfelde, 18209
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Tübingen, D-72076
India4 sites
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Bangalore, 560079
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Hyderabaad, 500082
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Jaipur, 302023
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Secunderabad, 500 003
Romania4 sites
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Baia Mare, 430110
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Bucharest, 10584
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Cluj-Napoca, 400006
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Iași, 700656
Peru3 sites
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Arequipa
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Lima, Lima 27
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Pueblo Libre, Lima 21
South Korea3 sites
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Daejeon, 302-799
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Pusan, 602-739
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Seoul, 150-713
Russia2 sites
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Moscow, 115522
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Saint Petersburg, 115522
Chile1 site
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Santiago
About this study
Official title: A Phase 2 Dose-Ranging Study of Multiple Subcutaneous Doses of LY2439821 (an Anti-IL-17 Antibody) in Patients With Active Rheumatoid Arthritis on Concomitant DMARD Therapy
The primary purpose of the study is to help answer the following research questions, and not to provide treatment for Rheumatoid Arthritis (RA):
- The safety of LY2439821 and any side effects that might be associated with it.
- Whether LY2439821 can help participants with active RA.
- How much LY2439821 should be given to participants.
Read the detailed description
Study I1F-MC-RHAK is a multicenter study in participants with active RA on concomitant conventional DMARD therapy. The study is a Phase 2 study with 2 parts. Part A is a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging design and Part B is an optional, open-label extension design. Two participant populations will be evaluated in this study: bDMARD-naive participants and TNFα-IR participants. Participants in Part A receive multiple subcutaneous injections of LY2439821 [bDMARD-naive participants: 0 (placebo), 3, 10, 30, 80, or 180 mg; TNFα-IR participants: 0 (placebo), 80 or 180 mg] at Weeks 0, 1, 2, 4, 6, 8, and 10. Participants in Part B receive subcutaneous injections of LY2439821 160 mg at Weeks 16, 18, and 20, and every 4 weeks thereafter through Week 60. Participants who complete both Part A and B have a total study participation of up to approximately 72 to 84 weeks.
- Conditions
- Rheumatoid Arthritis
- Being tested
- LY2439821, Placebo
- Keywords
- rheumatoid arthritis, RA
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2439821Biological
Also called ixekizumab
Subcutaneous
PlaceboDrug
Subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| 3 mg LY2439821 (bDMARD-naive population) | Experimental | 3 milligrams (mg) LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. [Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD)] Receives: Biological: LY2439821 |
| 10 mg LY2439821 (bDMARD-naive population) | Experimental | 10 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. Receives: Biological: LY2439821 |
| 30 mg LY2439821 (bDMARD-naive population) | Experimental | 30 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. Receives: Biological: LY2439821 |
| 80 mg LY2439821 (bDMARD-naive population) | Experimental | 80 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. Receives: Biological: LY2439821 |
| 180 mg LY2439821 (bDMARD-naive population) | Experimental | 180 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. Receives: Biological: LY2439821 |
| 80 mg LY2439821 (TNFa-IR population) | Experimental | 80 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. [Tumor Necrosis Factor Alpha-Inadequate Responder (TNFα-IR)] Receives: Biological: LY2439821 |
| 180 mg LY2439821 (TNFa-IR population) | Experimental | 180 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. Receives: Biological: LY2439821 |
| Placebo (bDMARD-naive population) | Placebo comparator | Placebo at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. Receives: Drug: Placebo |
| Placebo (TNFa-IR population) | Placebo comparator | Placebo at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Response Relationship Measured by the Percentage of Participants With American College of Rheumatology (ACR) 20 Response in bDMARD-Naive Population
ACR20 responders are participants with at least 20% improvement from baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: Health Assessment Questionnaire-Disability Index (HAQ-DI) which measured participants perceived degree of difficulty performing daily activities, C-reactive Protein (CRP), Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), Patient's Global Assessment of Disease Activity-VAS(PtGADA-VAS), and Physician's Global Assessment of Disease Activity-VAS (PhGA-VAS). Missing values were imputed using Non-Responder Imputation (NRI). Percentage of participants achieving ACR20 response was calculated as: (number of ACR20 responders / number of participants treated) * 100.
Measured: Week 12
Secondary outcomes (36)
Percentage of Participants With ACR20 Response in Tumor Necrosis Factor Alpha-Inadequate Responder (TNFα-IR) Population
ACR20 responders were participants with at least 20% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. Missing values were imputed using NRI. Percentage of participants achieving ACR20 response was calculated as: (number of ACR20 responders / number of participants treated) * 100.
Measured: Week 12
Smallest Doses That Achieve 10%, 50%, and 90% of the Maximum ACR 20 Response in bDMARD-Naive Population
ACR20 responders are participants with at least 20% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. The model used in the dose response analysis was used to estimate the doses that achieved 10%, 50%, and 90% of the maximal drug efficacy. Missing values were imputed using NRI. The log transformed dose was evaluated.
Measured: Week 12
Smallest Doses That Achieved 10%, 50%, and 90% of the Maximum Disease Activity Score (DAS) 28 Response in bDMARD-Naive Population
DAS modified included the 28 diarthrodial joint count (DAS28) that consisted of a composite score of the following variables: TJC out of 28 (TJC28), SJC out of 28 (SJC28), CRP [milligrams per liter (mg/L)], and PtGADA on a 0 to 100 millimeter (mm) VAS ranging from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). DAS28 was calculated as: DAS28 - CRP = 0.56(square root of TJC28) + 0.28(square root of SJC28) + 0.36(ln[CRP +1]) + 0.014(VAS) + 0.96.
Measured: Week 12
Smallest Doses That Achieve 10%, 50%, and 90% of the Maximum ACR50 Response in bDMARD-Naive Population
ACR50 responders were participants with at least 50% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. Missing values were imputed using NRI.
Measured: Week 12
Change From Baseline in Disease Activity Score (DAS28)-Part A
DAS28 consisted of a composite score of the following variables: TJC28, SJC28, CRP, and PtGADA-VAS. DAS28 was calculated as: DAS28 - CRP =0.56(square root TJC28) + 0.28(square root SJC28) + 0.36(ln[CRP +1]) + 0.014(VAS) + 0.96. A negative change indicated an improvement.
Measured: Baseline, up to Week 12
Change From Baseline in DAS28 - Part B
DAS28 consisted of a composite score of the following variables: TJC28, SJC28, CRP, and PtGADA-VAS. DAS28 was calculated as: DAS28 - CRP =0.56(square root TJC28) + 0.28(square root SJC28) + 0.36(ln[CRP +1]) + 0.014(VAS) + 0.96. A negative change indicated an improvement.
Measured: Baseline, Week 64
Percentage of Participants With ACR20/50/70 Response - Part A
ACR20 (or ACR50 or ACR70) responders were participants with at least 20% (or 50% or 70%, respectively) improvement from baseline TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. Missing values were imputed using NRI. Percentage of participants was calculated as: (number of ACR20 [or ACR50 or ACR70] responders per treatment arm) / (total number of participants per treatment arm) * 100.
Measured: Week 12
Percentage of Participants With of ACR20/50/70 Response - Part B
ACR20 (or ACR50 or ACR70) responders were participants with at least 20% (or 50% or 70% respectively) improvement from baseline TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. Missing values were imputed using NRI. Percentage of participants was calculated as: (number of ACR20 [or ACR50 or ACR70] responders per treatment arm) / (total number of participants per treatment arm) * 100].
Measured: Week 64
Change From Baseline in Individual Components of the ACR Core Set-TJC - Part A
TJC was determined by examination of 28 joint counts that were assessed for tenderness by pressure and joint manipulation on physical examination. The participant was asked for pain sensations on these manipulations and was watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-non-tender dichotomy. Joint assessments for each participant were performed by the same assessor, when possible, throughout the study to minimize variation. Replaced, ankylosed, arthrodesed joints were identified by the investigator and excluded from evaluation during the study. Any joints that required intra-articular injections during the study were excluded from evaluation from the time of the injection to the conclusion of the study. The number of tender joints ranged from 0-28. A negative change indicated fewer tender joints.
Measured: Baseline, up to Week 12
Change From Baseline in Individual Components of the ACR Core Set-TJC - Part B
TJC was determined by examination of 28 joint counts that were assessed for tenderness by pressure and joint manipulation on physical examination. The participant was asked for pain sensations on these manipulations and was watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-non-tender dichotomy. Joint assessments for each participant were performed by the same assessor, when possible, throughout the study to minimize variation. Replaced, ankylosed, arthrodesed joints were identified by the investigator and excluded from evaluation during the study. Any joints that required intra-articular injections during the study were excluded from evaluation from the time of the injection to the conclusion of the study. The number of tender joints ranged from 0-28. A negative change indicated fewer tender joints.
Measured: Baseline, Week 64
Change From Baseline in Individual Components of the ACR Core Set-SJC - Part A
SJC was determined by examination of 28 joint that were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. Swelling secondary to osteoarthrosis was assessed as not swollen, unless there was unmistakable fluctuation. Joint assessments for each participant were performed by the same assessor, when possible, throughout the study to minimize variation. Replaced, ankylosed, or arthrodesed joints were identified by the investigator and were excluded from evaluation during the study. Any joints that required intra-articular injections over the course of the study were excluded from evaluation from the time of the injection to the conclusion of the study. The number of swollen joints count ranged from 0-28. A negative change indicated fewer swollen joints.
Measured: Baseline, up to Week 12
Change From Baseline in Individual Components of the ACR Core Set-SJC - Part B
SJC was determined by examination of 28 joint that were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. Swelling secondary to osteoarthrosis was assessed as not swollen, unless there was unmistakable fluctuation. Joint assessments for each participant were performed by the same assessor, when possible, throughout the study to minimize variation. Replaced, ankylosed, or arthrodesed joints were identified by the investigator and were excluded from evaluation during the study. Any joints that required intra-articular injections over the course of the study were excluded from evaluation from the time of the injection to the conclusion of the study. The number of swollen joints ranged from 0-28. A negative change indicated fewer swollen joints.
Measured: Baseline, Week 64
Change From Baseline in Individual Components of the ACR Core Set-PAAP VAS - Part A
Participants were asked to assess his/her current level of arthritis pain by marking a vertical tick on a 100-mm horizontal VAS with the left end (0 mm) marked as "no pain" and the right end (100 mm) marked "worst possible pain." The scale was administered prior to the TJC and SJC count examinations. Results were expressed in mm measured between the left end of the scale and the crossing point of the vertical line of the tick. A negative change indicated a lessening of the participant's arthritis pain.
Measured: Baseline, up to Week 12
Change From Baseline in Individual Components of the ACR Core Set-PAAP-VAS - Part B
Participants were asked to assess his/her current level of arthritis pain by marking a vertical tick on a 100-mm horizontal VAS with the left end (0 mm) marked as "no pain" and the right end (100 mm) marked "worst possible pain". The scale was administered prior to the TJC and SJC count examinations. Results were expressed in mm measured between the left end of the scale and the crossing point of the vertical line of the tick. A negative change indicated a lessening of the participant's arthritis pain.
Measured: Baseline, Week 64
Change From Baseline in Individual Components of the ACR Core Set - PtGADA-VAS - Part A
The participant was asked to give an overall assessment of his/her current arthritis disease activity. The participants response was recorded by marking a vertical tick on a 100-mm VAS with the left end (0 mm) marked as "no arthritis activity" to the right end (100 mm) marked "extremely active arthritis." A negative change indicated an improvement in the participant's assessment of disease activity.
Measured: Baseline, up to Week 12
Change From Baseline in Individual Components of the ACR Core Set - PtGADA-VAS - Part B
The participant was asked to give an overall assessment of his/her current arthritis disease activity. The participants response was recorded by marking a vertical tick on a 100-mm VAS with the left end (0 mm) marked as "no arthritis activity" to the right end (100 mm) marked "extremely active arthritis." A negative change indicated an improvement in the participant's assessment of disease activity.
Measured: Baseline, Week 64
Change From Baseline in Individual Components of the ACR Core Set - PhGA-VAS - Part A
The investigator gave an overall assessment of the severity of the participants disease activity. The physician's response was recorded by marking a vertical tick on a 100-mm VAS with the left end (0 mm) marked as "no arthritis activity" and the right end (100 mm) marked as "extremely active arthritis." A negative change indicated a lessening in the severity of the participant's disease activity.
Measured: Baseline, up to Week 12
Change From Baseline in Individual Components of the ACR Core Set - PhGA-VAS - Part B
The investigator gave an overall assessment of the severity of the participant's disease activity. The physician's response was recorded by marking a vertical tick on a 100-mm VAS with the left end (0 mm) marked as "no arthritis activity" and the right end (100 mm) marked as "extremely active arthritis." A negative change indicated a lessening in the severity of the participant's disease activity.
Measured: Baseline, Week 64
Change From Baseline in Individual Components of the ACR Core Set - CRP - Part A
CRP is a biological marker of disease activity. A negative change indicated an improvement in participant's disease activity.
Measured: Baseline, up to Week 12
Change From Baseline in Individual Components of the ACR Core Set - CRP - Part B
CRP is a biological marker of disease activity. A negative change indicated an improvement in participant's disease activity.
Measured: Baseline, Week 64
Percentage of Participants in European League Against Rheumatism Responder Index (EULAR) 28 - Part A
Assessment of participant's rheumatoid arthritis (RA) by the EULAR that is based on the DAS 28 joint count. Participants were categorized as non-responders or responders (moderate responders + good responders). Percentage of participants was calculated as: (number of responders / number of participants) * 100.
Measured: Week 12
Percentage of Participants in EULAR28 - Part B
Assessment of participant's RA by the EULAR that is based on the DAS28 joint count. Participants were categorized as non-responders or responders (moderate responders + good responders). Percentage of participants was calculated as: (number of responders / number of participants) * 100.
Measured: Week 64
ACR-N - Part A
ACR-N was a continuous measure of clinical, laboratory and functional outcomes in RA that characterized the percentage of improvement in RA disease activity from baseline. The index was defined as the lowest of either: the percent change in TJC, the percent change in SJC, or the median percent change of the remaining 5 ACR core criteria: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. For each criterion, percent change was calculated as: [(post baseline value - baseline value) / baseline value] * 100.
Measured: Week 12
ACR-N - Part B
ACR-N was a continuous measure of clinical, laboratory and functional outcomes in RA that characterized the percentage of improvement in RA disease activity from baseline. The index was defined as the lowest of either: the percent change in TJC, the percent change in SJC, or the median percent change of the remaining 5 ACR core criteria: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. For each criterion, percent change was calculated as: [(post baseline value - baseline value)/baseline value] * 100.
Measured: Week 64
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale - Part A
The FACIT Fatigue Scale was a brief participant-reported questionnaire measure of fatigue and consisted of 13 items that assessed tiredness, weakness and difficulty conducting usual activities due to fatigue. Each question was scored on a 5-point scale from 0 (not at all) to 4 (very much). Scores range from 0 to 52, with higher scores indicating greater fatigue. For missing data, scores were prorated using the average of the other answers in the scales as long as more than 50% of the items were answered. A negative change indicated less fatigue.
Measured: Baseline, up to Week 12
Change From Baseline in FACIT Fatigue Scale - Part B
The FACIT-Fatigue Scale was a brief participant-reported questionnaire measure of fatigue and consisted of 13 items that assessed tiredness, weakness and difficulty conducting usual activities due to fatigue. Each question was scored on a 5-point scale from 0 (not at all) to 4 (very much). Scores range from 0 to 52, with higher scores indicating greater fatigue. For missing data, scores were prorated using the average of the other answers in the scales as long as more than 50% of the items were answered. A negative change indicated less fatigue.
Measured: Baseline, Week 64
Change From Baseline in Duration of Morning Stiffness (Minutes) - Part A
The investigator queried the participants about the duration of morning stiffness in and around their joints and the results (in minutes) were recorded by the investigator. Duration was the time from when the participants woke up to when normal activities could be resumed. Durations recorded as longer than 12 hours (720 minutes) were summarized as 720 minutes. An increase in duration from baseline indicated a joint worsening and a decrease from baseline indicated joint improvement.
Measured: Baseline, up to Week 12
Change From Baseline in Duration of Morning Stiffness (Minutes) - Part B
The investigator queried the participants about the duration of morning stiffness in and around their joints and the results (in minutes) were recorded by the investigator. Duration was the time from when the participants woke up to when normal activities could be resumed. Durations recorded as longer than 12 hours (720 minutes) were summarized as 720 minutes. An increase in duration from baseline indicated a joint worsening and a decrease from baseline indicated joint improvement.
Measured: Baseline, Week 64
Change From Baseline in HAQ-DI - Part A
HAQ-DI was a participant-reported questionnaire that consisted of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). The highest score for any question in a category was the score of that category unless special aids or devices or help from another person was required. Answers for at least 6 of the 8 disability domains were required to compute the participant's HAQ-DI score. If the participant had scores for fewer than 6 categories, the HAQ-DI score was considered missing. The HAQ-DI score was calculated as the sum of the category scores divided by the number of categories scored, with a possible scores range of 0 to 3. Negative mean changes from baseline indicated improvement.
Measured: Baseline, up to Week 12
Change From Baseline in HAQ-DI - Part B
HAQ-DI was a participant-reported questionnaire that consisted of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). The highest score for any question in a category was the score of that category unless special aids or devices or help from another person was required. Answers for at least 6 of the 8 disability domains were required to compute the participant's HAQ-DI score. If the participant had scores for fewer than 6 categories, the HAQ-DI score was considered missing. The HAQ-DI score was calculated as the sum of the category scores divided by the number of categories scored, with a possible scores range from 0 to 3. Negative mean changes from baseline indicated improvement.
Measured: Baseline, Week 64
Relationship Between Exposure and Response of Individual Components of the ACR Core Set
Measured: Through Week 72
Relationship Between Exposure and Response of ACR20/50/70/N
Measured: Through Week 72
Relationship Between Exposure and Response of DAS28
Measured: Through Week 72
Relationship Between Exposure and Response of EULAR28
Measured: Through Week 72
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2439821 at Steady State
Evaluable PK concentrations from all time points, including data from placebo participants who elected active treatment in Part B, were combined and utilized in a population approach to determine the population median estimates and 90% confidence intervals at steady state. Day 0 and Week 6 postdose samples were collected as late as possible during the dosing visit (in other words, the postdose samples were collected at the end of their respective visits).
Measured: Predose: Day 0, Day 1 or 2 or 3, Day 7, Weeks 6, 10, 16, 40 and 64 and Postdose: Day 0 and Week 6
Percentage of Participants With Anti-LY2439821 Antibodies
Treatment-emergent anti-LY2439821 antibody positive participants were defined as a titer change from baseline that was at least 2 dilutions (4-fold) increase. Participants must have had an assessment to be classified as treatment emergent antibody positive or negative.
Measured: Week 16, Week 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionMar 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 448 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966875
- Sponsor's protocol ID
- 12061
- Other IDs
- I1F-MC-RHAK
- Status last verified
- Apr 2016
- First submitted
- 25 Aug 2009
- Last updated
- 26 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Genovese MC, Braun DK, Erickson JS, Berclaz PY, Banerjee S, Heffernan MP, Carlier H. Safety and Efficacy of Open-label Subcutaneous Ixekizumab Treatment for 48 Weeks in a Phase II Study in Biologic-naive and TNF-IR Patients with Rheumatoid Arthritis. J Rheumatol. 2016 Feb;43(2):289-97. doi: 10.3899/jrheum.140831. Epub 2015 Dec 15.
PubMed 26669919Genovese MC, Greenwald M, Cho CS, Berman A, Jin L, Cameron GS, Benichou O, Xie L, Braun D, Berclaz PY, Banerjee S. A phase II randomized study of subcutaneous ixekizumab, an anti-interleukin-17 monoclonal antibody, in rheumatoid arthritis patients who were naive to biologic agents or had an inadequate response to tumor necrosis factor inhibitors. Arthritis Rheumatol. 2014 Jul;66(7):1693-704. doi: 10.1002/art.38617.
PubMed 24623718
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Dose-Ranging Study of Multiple Subcutaneous Doses of LY2439821 (an Anti-IL-17 Antibody) in Patients With Active Rheumatoid Arthritis on Concomitant DMARD Therapy
- ClinicalTrials.gov ID
- NCT00966875
- Acronym / sponsor ID
- 12061
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, RA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 448 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 27 Aug 2009 (estimated)
- Results
- Posted 26 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of the study is to help answer the following research questions, and not to provide treatment for Rheumatoid Arthritis (RA):
- The safety of LY2439821 and any side effects that might be associated with it.
- Whether LY2439821 can help participants with active RA.
- How much LY2439821 should be given to participants.
Detailed description
Study I1F-MC-RHAK is a multicenter study in participants with active RA on concomitant conventional DMARD therapy. The study is a Phase 2 study with 2 parts. Part A is a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging design and Part B is an optional, open-label extension design. Two participant populations will be evaluated in this study: bDMARD-naive participants and TNFα-IR participants. Participants in Part A receive multiple subcutaneous injections of LY2439821 [bDMARD-naive participants: 0 (placebo), 3, 10, 30, 80, or 180 mg; TNFα-IR participants: 0 (placebo), 80 or 180 mg] at Weeks 0, 1, 2, 4, 6, 8, and 10. Participants in Part B receive subcutaneous injections of LY2439821 160 mg at Weeks 16, 18, and 20, and every 4 weeks thereafter through Week 60. Participants who complete both Part A and B have a total study participation of up to approximately 72 to 84 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 3 mg LY2439821 (bDMARD-naive population) | Experimental | Biological: LY24398213 milligrams (mg) LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. [Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD)] |
| 10 mg LY2439821 (bDMARD-naive population) | Experimental | Biological: LY243982110 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. |
| 30 mg LY2439821 (bDMARD-naive population) | Experimental | Biological: LY243982130 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. |
| 80 mg LY2439821 (bDMARD-naive population) | Experimental | Biological: LY243982180 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. |
| 180 mg LY2439821 (bDMARD-naive population) | Experimental | Biological: LY2439821180 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. |
| 80 mg LY2439821 (TNFa-IR population) | Experimental | Biological: LY243982180 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. [Tumor Necrosis Factor Alpha-Inadequate Responder (TNFα-IR)] |
| 180 mg LY2439821 (TNFa-IR population) | Experimental | Biological: LY2439821180 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. |
| Placebo (bDMARD-naive population) | Placebo comparator | Drug: PlaceboPlacebo at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. |
| Placebo (TNFa-IR population) | Placebo comparator | Drug: PlaceboPlacebo at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- You must be between the ages of 18 and 75
- You must have active RA
- You must be regularly using methotrexate (MTX) for at least 12 weeks before your participation in this study
- You must have been treated with at least 1 biologic TNFα inhibitor therapy and either had an insufficient response to at least 3 months of treatment OR have been intolerant of such treatment
- You must be regularly using at least 1 conventional DMARD in a stable treatment regimen
Key exclusion criteria (24 listed)
- You are concomitantly using non-steroidal anti-inflammatory drugs (NSAIDS), unless you are on a stable dose within the last 2 weeks
- You are a woman who is lactating or breast feeding
- You have donated more than 300 milliliters (mL) of blood within the last month
- You have received glucocorticoid administered by intra-articular, intramuscular, or intravenous injection or oral corticosteroids at an average daily dose of greater than 10 mg per day of prednisone or its equivalent within the last 4 weeks
- You had surgery on a joint that is to be assessed in the study within 2 months of study enrollment, or will require such during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY2439821Also: ixekizumabSubcutaneous | Biological | 10 mg LY2439821 (bDMARD-naive population), 180 mg LY2439821 (TNFa-IR population), 180 mg LY2439821 (bDMARD-naive population), 3 mg LY2439821 (bDMARD-naive population), 30 mg LY2439821 (bDMARD-naive population), 80 mg LY2439821 (TNFa-IR population), 80 mg LY2439821 (bDMARD-naive population) |
| PlaceboSubcutaneous | Drug | Placebo (TNFa-IR population), Placebo (bDMARD-naive population) |
Primary outcome
Dose-Response Relationship Measured by the Percentage of Participants With American College of Rheumatology (ACR) 20 Response in bDMARD-Naive Population
Time frame: Week 12
ACR20 responders are participants with at least 20% improvement from baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: Health Assessment Questionnaire-Disability Index (HAQ-DI) which measured participants perceived degree of difficulty performing daily activities, C-reactive Protein (CRP), Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), Patient's Global Assessment of Disease Activity-VAS(PtGADA-VAS), and Physician's Global Assessment of Disease Activity-VAS (PhGA-VAS). Missing values were imputed using Non-Responder Imputation (NRI). Percentage of participants achieving ACR20 response was calculated as: (number of ACR20 responders / number of participants treated) * 100.
36 secondary outcomes
Percentage of Participants With ACR20 Response in Tumor Necrosis Factor Alpha-Inadequate Responder (TNFα-IR) Population
Time frame: Week 12
Smallest Doses That Achieve 10%, 50%, and 90% of the Maximum ACR 20 Response in bDMARD-Naive Population
Time frame: Week 12
Smallest Doses That Achieved 10%, 50%, and 90% of the Maximum Disease Activity Score (DAS) 28 Response in bDMARD-Naive Population
Time frame: Week 12
Smallest Doses That Achieve 10%, 50%, and 90% of the Maximum ACR50 Response in bDMARD-Naive Population
Time frame: Week 12
Change From Baseline in Disease Activity Score (DAS28)-Part A
Time frame: Baseline, up to Week 12
Change From Baseline in DAS28 - Part B
Time frame: Baseline, Week 64
Percentage of Participants With ACR20/50/70 Response - Part A
Time frame: Week 12
Percentage of Participants With of ACR20/50/70 Response - Part B
Time frame: Week 64
Change From Baseline in Individual Components of the ACR Core Set-TJC - Part A
Time frame: Baseline, up to Week 12
Change From Baseline in Individual Components of the ACR Core Set-TJC - Part B
Time frame: Baseline, Week 64
Change From Baseline in Individual Components of the ACR Core Set-SJC - Part A
Time frame: Baseline, up to Week 12
Change From Baseline in Individual Components of the ACR Core Set-SJC - Part B
Time frame: Baseline, Week 64
Change From Baseline in Individual Components of the ACR Core Set-PAAP VAS - Part A
Time frame: Baseline, up to Week 12
Change From Baseline in Individual Components of the ACR Core Set-PAAP-VAS - Part B
Time frame: Baseline, Week 64
Change From Baseline in Individual Components of the ACR Core Set - PtGADA-VAS - Part A
Time frame: Baseline, up to Week 12
Change From Baseline in Individual Components of the ACR Core Set - PtGADA-VAS - Part B
Time frame: Baseline, Week 64
Change From Baseline in Individual Components of the ACR Core Set - PhGA-VAS - Part A
Time frame: Baseline, up to Week 12
Change From Baseline in Individual Components of the ACR Core Set - PhGA-VAS - Part B
Time frame: Baseline, Week 64
Change From Baseline in Individual Components of the ACR Core Set - CRP - Part A
Time frame: Baseline, up to Week 12
Change From Baseline in Individual Components of the ACR Core Set - CRP - Part B
Time frame: Baseline, Week 64
Percentage of Participants in European League Against Rheumatism Responder Index (EULAR) 28 - Part A
Time frame: Week 12
Percentage of Participants in EULAR28 - Part B
Time frame: Week 64
ACR-N - Part A
Time frame: Week 12
ACR-N - Part B
Time frame: Week 64
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale - Part A
Time frame: Baseline, up to Week 12
Change From Baseline in FACIT Fatigue Scale - Part B
Time frame: Baseline, Week 64
Change From Baseline in Duration of Morning Stiffness (Minutes) - Part A
Time frame: Baseline, up to Week 12
Change From Baseline in Duration of Morning Stiffness (Minutes) - Part B
Time frame: Baseline, Week 64
Change From Baseline in HAQ-DI - Part A
Time frame: Baseline, up to Week 12
Change From Baseline in HAQ-DI - Part B
Time frame: Baseline, Week 64
Relationship Between Exposure and Response of Individual Components of the ACR Core Set
Time frame: Through Week 72
Relationship Between Exposure and Response of ACR20/50/70/N
Time frame: Through Week 72
Relationship Between Exposure and Response of DAS28
Time frame: Through Week 72
Relationship Between Exposure and Response of EULAR28
Time frame: Through Week 72
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2439821 at Steady State
Time frame: Predose: Day 0, Day 1 or 2 or 3, Day 7, Weeks 6, 10, 16, 40 and 64 and Postdose: Day 0 and Week 6
Percentage of Participants With Anti-LY2439821 Antibodies
Time frame: Week 16, Week 64
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26669919Genovese MC, Braun DK, Erickson JS, Berclaz PY, Banerjee S, Heffernan MP, Carlier H. Safety and Efficacy of Open-label Subcutaneous Ixekizumab Treatment for 48 Weeks in a Phase II Study in Biologic-naive and TNF-IR Patients with Rheumatoid Arthritis. J Rheumatol. 2016 Feb;43(2):289-97. doi: 10.3899/jrheum.140831. Epub 2015 Dec 15.
- Derived from this study: PubMed 24623718Genovese MC, Greenwald M, Cho CS, Berman A, Jin L, Cameron GS, Benichou O, Xie L, Braun D, Berclaz PY, Banerjee S. A phase II randomized study of subcutaneous ixekizumab, an anti-interleukin-17 monoclonal antibody, in rheumatoid arthritis patients who were naive to biologic agents or had an inadequate response to tumor necrosis factor inhibitors. Arthritis Rheumatol. 2014 Jul;66(7):1693-704. doi: 10.1002/art.38617.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
75 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LY2439821 in people with Rheumatoid Arthritis, run by Eli Lilly and Company at 75 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 75 sites in United States, Poland, Taiwan, Argentina, Germany and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Response Relationship Measured by the Percentage of Participants With American College of Rheumatology (ACR) 20 Response in bDMARD-Naive Population (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00966875, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2016.