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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


Phase 2
18 Years
75 Years
Not Enrolling
Both
Rheumatoid Arthritis

Thank you

Trial Information

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 I1F-MC-RHAK is a multicenter study in patients with active rheumatoid arthritis on
concomitant conventional disease modifying anti-rheumatic drug (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 patient populations will be evaluated in this study: biologic disease modifying
anti-rheumatic drug [bDMARD]-naive patients and tumor necrosis factor alpha-inadequate
responder [TNFα-IR] patients. Patients in Part A receive multiple subcutaneous (SC)
injections of LY2439821 (bDMARD-naive patients: 0 [placebo], 3, 10, 30, 80, or 180 mg;
TNFα-IR patients: 0 [placebo], 80 or 180 mg) at Weeks 0, 1, 2, 4, 6, 8, and 10. Patients in
Part B receive SC injections of LY2439821 160 mg at Weeks 16, 18, and 20, and every 4 weeks
thereafter through Week 60. Patients who complete both Part A and B have a total study
participation of up to approximately 72 to 84 weeks.


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 mL of blood within the last month

- You have received glucocorticoid administered by intra-articular, intramuscular, or
intravenous (IV) 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 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 biologic DMARD therapy such as TNFα, 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, 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 biologic DMARD 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Dose-response relationship measured by the proportion of American College of Rheumatology (ACR) 20 responders; Biologic disease modifying anti-rheumatic drug-naive population (bDMARD-naive) only

Outcome Time Frame:

Week 12

Safety Issue:

No

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

12061

NCT ID:

NCT00966875

Start Date:

August 2009

Completion Date:

June 2012

Related Keywords:

  • Rheumatoid Arthritis
  • rheumatoid arthritis
  • RA
  • Arthritis
  • Arthritis, Rheumatoid

Name

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Denver, Colorado  
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.Durham, North Carolina  
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.Phoenix, Arizona  85012
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.Greenbrae, California  94904
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.Jacksonville, Florida  32256
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.Athens, Georgia  30607
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.Chicago, Illinois  60674
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.Bethesda, Maryland  20817
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.Kalamazoo, Michigan  49048
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.St Joseph, Missouri  64507
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.Tulsa, Oklahoma  74136
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.Dunmore, Pennsylvania  18512
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.Greenville, South Carolina  29605
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.Memphis, Tennessee  38138
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.Bedford, Texas  76022
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.Salt Lake City, Utah  84106
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.Norfolk, Virginia  23502
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.Seattle, Washington  98133
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.Marshfield, Wisconsin  54449
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.Washington, District of Columbia  20007
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.Coeur D'Alene, Idaho  83814