A Study in Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01253265
First received: December 1, 2010
Last updated: January 11, 2012
Last verified: January 2012
  Purpose

The purpose of this study is to evaluate the safety and tolerability of multiple doses of LY2439821 in Japanese patients with rheumatoid arthritis.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: LY2439821
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multiple-Dose, Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY2439821 in Japanese Patients With Rheumatoid Arthritis on Concomitant Methotrexate Treatment

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Number of participants with Clinically significant effects [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline to 16 week endpoint in C-Reactive Protein [ Time Frame: Baseline, 16 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 16 week endpoint in Erythrocyte Sedimentation Rate [ Time Frame: Baseline, 16 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26 week endpoint in Neutrophil counts [ Time Frame: Baseline, 26 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26 week endpoint in Lymphocyte subsets [ Time Frame: Baseline, 26 weeks ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics - Area under the concentration-time curve (AUC) [ Time Frame: Baseline, days 7, 14, 28, 42, 56, 70, 72, 74, 77, 80, 84, 98, 126 and 182 ] [ Designated as safety issue: No ]
  • Pharmacokinetics - Maximum plasma drug concentration (Cmax) [ Time Frame: Baseline, days 7, 14, 28, 42, 56, 70, 72, 74, 77, 80, 84, 98, 126 and 182 ] [ Designated as safety issue: No ]
  • Pharmacokinetics - Time of maximum observed drug concentration [ Time Frame: Baseline, days 7, 14, 28, 42, 56, 70, 72, 74, 77, 80, 84, 98, 126 and 182 ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: May 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 30 mg LY2439821
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
Drug: LY2439821
Administered subcutaneously
Experimental: 80 mg LY2439821
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
Drug: LY2439821
Administered subcutaneously
Experimental: 180 mg LY2439821
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
Drug: LY2439821
Administered subcutaneously
Placebo Comparator: Placebo
Placebo is administered subcutaneously in the same manner as active drug in each dose group
Drug: Placebo
Administered subcutaneously
Experimental: 120 mg LY2439821
Administered subcutaneously at 240 mg as a single loading dose followed by 120 mg every week
Drug: LY2439821
Administered subcutaneously

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ambulatory male or female patients between the ages of 20 and 75 years
  • Male patients: Agree to use a reliable method of birth control during the study including barrier contraceptives or a monogamous relationship with a partner who is not child bearing. Female patients: Are women who test negative for pregnancy at the time of entry based on a pregnancy test and are not breast feeding. Women of child bearing potential must agree to use a reliable method of birth control during the study.
  • Patients who are between the body weight of 40 and 105 kg
  • Patients who have an established diagnosis of Rheumatoid Arthritis (RA)
  • Patients who have C reactive protein measurement > upper limit of normal or erythrocyte sedimentation rate of at least 28 mm/hr
  • Patients who have been treated with regular use of Methotrexate (MTX) for at least 12 weeks, and stable treatment (at least 7.5 mg/week) for at least 8 weeks
  • Patients who have given written informed consent approved by the Sponsor and the Institutional Review Board (IRB) governing the investigational site
  • Patients who have reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion Criteria:

  • Patients who use oral corticosteroids at average daily doses of >10 mg/day of prednisone or its equivalent or use of variable doses of oral corticosteroids within the last 4 weeks
  • Patients who have had a live vaccination within the last 12 weeks, or intend to have a live vaccination during the course of the study, or have participated in a vaccine clinical study within the last 12 weeks
  • Patients who have a diagnosis of any systemic inflammatory condition other than RA
  • Patients who have evidence of active vasculitis or uveitis
  • Patients who have a diagnosis of Felty's syndrome
  • Patients who have had surgical treatment of a joint within the last 8 weeks, or will require it during the study
  • Patients who have had lymphoma, leukemia, or any malignancy within the last 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease
  • Patients who have suffered a serious bacterial infection within the last 12 weeks, or a recent or ongoing infection
  • Patients who have an evidence or suspicion of active tuberculosis (TB) by medical history, physical examination, and/or chest radiograph or documentation of TB by a positive purified protein derivative (PPD) test
  • Patients who have uncontrolled arterial hypertension characterized by a systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg
  • Patients who have an evidence of positive hepatitis B surface antigen, positive hepatitis B surface antibody, positive hepatitis B core antibody, or hepatitis B DNA (HBV DNA); an evidence of human immunodeficiency virus (HIV), evidence of hepatitis B; or an evidence of hepatitis C
  • Patients who have clinical laboratory test results at entry that are outside the normal reference range, or results with unacceptable deviations that are considered clinically significant by the investigator
  • Patients who have a serum creatinine >2.0 mg/dL
  • Patients who have known hypogammaglobulinemia or a serum IgG, IgM, or IgA concentration less than the lower limit of normal
  • Patients who have an abnormality in the 12 lead electrocardiogram (ECG).
  • Patients who have donated of blood more than 200 mL within the past 30 days, or more than 400 mL within the past 90 days
  • Patients who are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off label use of an investigational drug or device, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. For unapproved DMARDs, have received 30 days or 5 fold of the half life prior to inclusion whichever is longer
  • Patients who previously completed or withdrawn from this study or any other study investigating LY2439821
  • Patients who have been treated with any biologic DMARD currently or previously for 5 half lives
  • Patients who have had serious reaction to other biologic Disease-Modifying Anti-Rheumatic Drug (DMARDs)
  • Patients who have received non biologics DMARDs (other than MTX, sulfasalazine, bucillamine or hydroxychloroquine)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01253265

Locations
Japan
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.
Fukuoka, Japan, 820-8505
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.
Hyogo, Japan, 673-1462
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.
Ibaragi, Japan, 316-0035
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.
Nagasaki, Japan, 857-1165
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.
Niigata, Japan, 940-2085
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.
Okayama, Japan, 712-8044
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.
Shimane, Japan, 699-0293
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.
Tokyo, Japan, 164-8541
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01253265     History of Changes
Other Study ID Numbers: 13061, I1F-JE-RHAL
Study First Received: December 1, 2010
Last Updated: January 11, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 16, 2014