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A Study in Patients With Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

LY2439821

Placebo

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring rheumatoid arthritis, RA

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Placebo Comparator

Arm Label

3 mg LY2439821 (bDMARD-naive population)

10 mg LY2439821 (bDMARD-naive population)

30 mg LY2439821 (bDMARD-naive population)

80 mg LY2439821 (bDMARD-naive population)

180 mg LY2439821 (bDMARD-naive population)

80 mg LY2439821 (TNFa-IR population)

180 mg LY2439821 (TNFa-IR population)

Placebo (bDMARD-naive population)

Placebo (TNFa-IR population)

Arm Description

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)]

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.

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.

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.

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.

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)]

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

Change From Baseline in DAS28 - Part B

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.

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].

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.

Change From Baseline in Individual Components of the ACR Core Set-TJC - Part B

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.

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.

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.

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.

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.

Change From Baseline in Individual Components of the ACR Core Set - PtGADA-VAS - Part B

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.

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.

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.

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.

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.

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.

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.

ACR-N - Part B

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.

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.

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.

Change From Baseline in Duration of Morning Stiffness (Minutes) - Part B

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.

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.

Relationship Between Exposure and Response of Individual Components of the ACR Core Set

Relationship Between Exposure and Response of ACR20/50/70/N

Relationship Between Exposure and Response of DAS28

Relationship Between Exposure and Response of EULAR28

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).

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.

Full Information

NCT ID

NCT00966875

First Posted

August 25, 2009

Last Updated

April 20, 2016

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00966875

Brief Title

A Study in Patients With Rheumatoid Arthritis

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

August 2009 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

rheumatoid arthritis, RA

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

448 (Actual)

8. Arms, Groups, and Interventions

Arm Title

3 mg LY2439821 (bDMARD-naive population)

Arm Type

Experimental

Arm Description

Arm Title

10 mg LY2439821 (bDMARD-naive population)

Arm Type

Experimental

Arm Description

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.

Arm Title

30 mg LY2439821 (bDMARD-naive population)

Arm Type

Experimental

Arm Description

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.

Arm Title

80 mg LY2439821 (bDMARD-naive population)

Arm Type

Experimental

Arm Description

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.

Arm Title

180 mg LY2439821 (bDMARD-naive population)

Arm Type

Experimental

Arm Description

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.

Arm Title

80 mg LY2439821 (TNFa-IR population)

Arm Type

Experimental

Arm Description

Arm Title

180 mg LY2439821 (TNFa-IR population)

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo (bDMARD-naive population)

Arm Type

Placebo Comparator

Arm Description

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.

Arm Title

Placebo (TNFa-IR population)

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Biological

Intervention Name(s)

LY2439821

Other Intervention Name(s)

ixekizumab

Intervention Description

Subcutaneous

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Subcutaneous

Primary Outcome Measure Information:

Title

Dose-Response Relationship Measured by the Percentage of Participants With American College of Rheumatology (ACR) 20 Response in bDMARD-Naive Population

Description

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Percentage of Participants With ACR20 Response in Tumor Necrosis Factor Alpha-Inadequate Responder (TNFα-IR) Population

Description

Time Frame

Week 12

Title

Smallest Doses That Achieve 10%, 50%, and 90% of the Maximum ACR 20 Response in bDMARD-Naive Population

Description

Time Frame

Week 12

Title

Smallest Doses That Achieved 10%, 50%, and 90% of the Maximum Disease Activity Score (DAS) 28 Response in bDMARD-Naive Population

Description

Time Frame

Week 12

Title

Smallest Doses That Achieve 10%, 50%, and 90% of the Maximum ACR50 Response in bDMARD-Naive Population

Description

Time Frame

Week 12

Title

Change From Baseline in Disease Activity Score (DAS28)-Part A

Description

Time Frame

Baseline, up to Week 12

Title

Change From Baseline in DAS28 - Part B

Description

Time Frame

Baseline, Week 64

Title

Percentage of Participants With ACR20/50/70 Response - Part A

Description

Time Frame

Week 12

Title

Percentage of Participants With of ACR20/50/70 Response - Part B

Description

Time Frame

Week 64

Title

Change From Baseline in Individual Components of the ACR Core Set-TJC - Part A

Description

Time Frame

Baseline, up to Week 12

Title

Change From Baseline in Individual Components of the ACR Core Set-TJC - Part B

Description

Time Frame

Baseline, Week 64

Title

Change From Baseline in Individual Components of the ACR Core Set-SJC - Part A

Description

Time Frame

Baseline, up to Week 12

Title

Change From Baseline in Individual Components of the ACR Core Set-SJC - Part B

Description

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.

Time Frame

Baseline, Week 64

Title

Change From Baseline in Individual Components of the ACR Core Set-PAAP VAS - Part A

Description

Time Frame

Baseline, up to Week 12

Title

Change From Baseline in Individual Components of the ACR Core Set-PAAP-VAS - Part B

Description

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.

Time Frame

Baseline, Week 64

Title

Change From Baseline in Individual Components of the ACR Core Set - PtGADA-VAS - Part A

Description

Time Frame

Baseline, up to Week 12

Title

Change From Baseline in Individual Components of the ACR Core Set - PtGADA-VAS - Part B

Description

Time Frame

Baseline, Week 64

Title

Change From Baseline in Individual Components of the ACR Core Set - PhGA-VAS - Part A

Description

Time Frame

Baseline, up to Week 12

Title

Change From Baseline in Individual Components of the ACR Core Set - PhGA-VAS - Part B

Description

Time Frame

Baseline, Week 64

Title

Change From Baseline in Individual Components of the ACR Core Set - CRP - Part A

Description

CRP is a biological marker of disease activity. A negative change indicated an improvement in participant's disease activity.

Time Frame

Baseline, up to Week 12

Title

Change From Baseline in Individual Components of the ACR Core Set - CRP - Part B

Description

CRP is a biological marker of disease activity. A negative change indicated an improvement in participant's disease activity.

Time Frame

Baseline, Week 64

Title

Percentage of Participants in European League Against Rheumatism Responder Index (EULAR) 28 - Part A

Description

Time Frame

Week 12

Title

Percentage of Participants in EULAR28 - Part B

Description

Time Frame

Week 64

Title

ACR-N - Part A

Description

Time Frame

Week 12

Title

ACR-N - Part B

Description

Time Frame

Week 64

Title

Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale - Part A

Description

Time Frame

Baseline, up to Week 12

Title

Change From Baseline in FACIT Fatigue Scale - Part B

Description

Time Frame

Baseline, Week 64

Title

Change From Baseline in Duration of Morning Stiffness (Minutes) - Part A

Description

Time Frame

Baseline, up to Week 12

Title

Change From Baseline in Duration of Morning Stiffness (Minutes) - Part B

Description

Time Frame

Baseline, Week 64

Title

Change From Baseline in HAQ-DI - Part A

Description

Time Frame

Baseline, up to Week 12

Title

Change From Baseline in HAQ-DI - Part B

Description

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.

Time Frame

Baseline, Week 64

Title

Relationship Between Exposure and Response of Individual Components of the ACR Core Set

Time Frame

Through Week 72

Title

Relationship Between Exposure and Response of ACR20/50/70/N

Time Frame

Through Week 72

Title

Relationship Between Exposure and Response of DAS28

Time Frame

Through Week 72

Title

Relationship Between Exposure and Response of EULAR28

Time Frame

Through Week 72

Title

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2439821 at Steady State

Description

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

Title

Percentage of Participants With Anti-LY2439821 Antibodies

Description

Time Frame

Week 16, Week 64

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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

Peoria

State/Province

Arizona

ZIP/Postal Code

85381

Country

United States

Facility Name

City

La Mesa

State/Province

California

ZIP/Postal Code

91942

Country

United States

Facility Name

City

Palm Desert

State/Province

California

ZIP/Postal Code

92260

Country

United States

Facility Name

City

San Jose

State/Province

California

ZIP/Postal Code

95126

Country

United States

Facility Name

City

Santa Maria

State/Province

California

ZIP/Postal Code

93454

Country

United States

Facility Name

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

City

Westlake Village

State/Province

California

ZIP/Postal Code

91361

Country

United States

Facility Name

City

Denver

State/Province

Colorado

ZIP/Postal Code

80230

Country

United States

Facility Name

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20003

Country

United States

Facility Name

City

Lake Mary

State/Province

Florida

ZIP/Postal Code

32746

Country

United States

Facility Name

City

Melbourne

State/Province

Florida

ZIP/Postal Code

32901

Country

United States

Facility Name

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34239

Country

United States

Facility Name

City

St. Petersburg

State/Province

Florida

ZIP/Postal Code

33710

Country

United States

Facility Name

City

Tampa

State/Province

Florida

ZIP/Postal Code

33614

Country

United States

Facility Name

City

Vero Beach

State/Province

Florida

ZIP/Postal Code

32962

Country

United States

Facility Name

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30329

Country

United States

Facility Name

City

Rome

State/Province

Georgia

ZIP/Postal Code

30165

Country

United States

Facility Name

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404

Country

United States

Facility Name

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62704

Country

United States

Facility Name

City

Cumberland

State/Province

Maryland

ZIP/Postal Code

21502

Country

United States

Facility Name

City

Frederick

State/Province

Maryland

ZIP/Postal Code

21702

Country

United States

Facility Name

City

Wheaton

State/Province

Maryland

ZIP/Postal Code

20902

Country

United States

Facility Name

City

Bingham Farms

State/Province

Michigan

ZIP/Postal Code

48025

Country

United States

Facility Name

City

St Louis

State/Province

Missouri

ZIP/Postal Code

63117

Country

United States

Facility Name

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74135

Country

United States

Facility Name

City

Bethlehem

State/Province

Pennsylvania

ZIP/Postal Code

18017

Country

United States

Facility Name

City

Sellersville

State/Province

Pennsylvania

ZIP/Postal Code

18960

Country

United States

Facility Name

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29407

Country

United States

Facility Name

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

Facility Name

City

Sugar Land

State/Province

Texas

ZIP/Postal Code

77479

Country

United States

Facility Name

City

Temple

State/Province

Texas

ZIP/Postal Code

76508

Country

United States

Facility Name

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84143

Country

United States

Facility Name

City

Arlington

State/Province

Virginia

ZIP/Postal Code

22205

Country

United States

Facility Name

City

Olympia

State/Province

Washington

ZIP/Postal Code

98502

Country

United States

Facility Name

City

Spokane

State/Province

Washington

ZIP/Postal Code

99202

Country

United States

Facility Name

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53217

Country

United States

Facility Name

City

Buenos Aires

ZIP/Postal Code

C1425AWC

Country

Argentina

Facility Name

City

Quilmes

ZIP/Postal Code

B1878DVC

Country

Argentina

Facility Name

City

San Juan

ZIP/Postal Code

05400

Country

Argentina

Facility Name

City

Tucuman

ZIP/Postal Code

4000

Country

Argentina

Facility Name

City

Santiago

Country

Chile

Facility Name

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

City

Hamburg

ZIP/Postal Code

22415

Country

Germany

Facility Name

City

Hohenfelde

ZIP/Postal Code

18209

Country

Germany

Facility Name

City

Tubingen

ZIP/Postal Code

D-72076

Country

Germany

Facility Name

City

Bangalore

ZIP/Postal Code

560079

Country

India

Facility Name

City

Hyderabaad

ZIP/Postal Code

500082

Country

India

Facility Name

City

Jaipur

ZIP/Postal Code

302023

Country

India

Facility Name

City

Secunderabad

ZIP/Postal Code

500 003

Country

India

Facility Name

City

Daejeon

ZIP/Postal Code

302-799

Country

Korea, Republic of

Facility Name

City

Pusan

ZIP/Postal Code

602-739

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

150-713

Country

Korea, Republic of

Facility Name

City

Arequipa

Country

Peru

Facility Name

City

Lima

ZIP/Postal Code

Lima 27

Country

Peru

Facility Name

City

Pueblo Libre

ZIP/Postal Code

Lima 21

Country

Peru

Facility Name

City

Bytom

ZIP/Postal Code

41-902

Country

Poland

Facility Name

City

Czestochowa

ZIP/Postal Code

42-200

Country

Poland

Facility Name

City

Konskie

ZIP/Postal Code

26-200

Country

Poland

Facility Name

City

Koscian

ZIP/Postal Code

64-000

Country

Poland

Facility Name

City

Krakow

ZIP/Postal Code

30-510

Country

Poland

Facility Name

City

Poznan

ZIP/Postal Code

60-773

Country

Poland

Facility Name

City

Torun

ZIP/Postal Code

87-100

Country

Poland

Facility Name

City

Warsaw

ZIP/Postal Code

02-507

Country

Poland

Facility Name

City

Baia Mare

ZIP/Postal Code

430110

Country

Romania

Facility Name

City

Bucharest

ZIP/Postal Code

10584

Country

Romania

Facility Name

City

Cluj-Napoca

ZIP/Postal Code

400006

Country

Romania

Facility Name

City

Iasi

ZIP/Postal Code

700656

Country

Romania

Facility Name

City

Moscow

ZIP/Postal Code

115522

Country

Russian Federation

Facility Name

City

Saint Petersburg

ZIP/Postal Code

115522

Country

Russian Federation

Facility Name

City

Kaohsiung County

ZIP/Postal Code

833

Country

Taiwan

Facility Name

City

Taichung City

ZIP/Postal Code

40201

Country

Taiwan

Facility Name

City

Taichung

ZIP/Postal Code

404

Country

Taiwan

Facility Name

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

City

Tao-Yuan

ZIP/Postal Code

333

Country

Taiwan

12. IPD Sharing Statement

Citations:

PubMed Identifier

26669919

Citation

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.

Results Reference

derived

PubMed Identifier

24623718

Citation

Genovese 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.

Results Reference

derived

Learn more about this trial

A Study in Patients With Rheumatoid Arthritis

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