A Study in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01253265
• Other study ID #: 13061
• Secondary ID: I1F-JE-RHAL
• Status: Completed
• Phase: Phase 1
• First received: December 1, 2010
• Last updated: January 11, 2012
• Start date: May 2010
• Est. completion date: December 2011

Study information

• Verified date: January 2012
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• LY2439821
Administered subcutaneously
• Placebo
Administered subcutaneously

Locations

Country	Name	City	State
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	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	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	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	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	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	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	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Clinically significant effects		Up to 26 weeks	Yes
Secondary	Change from baseline to 16 week endpoint in C-Reactive Protein		Baseline, 16 weeks	No
Secondary	Change from baseline to 16 week endpoint in Erythrocyte Sedimentation Rate		Baseline, 16 weeks	No
Secondary	Change from baseline to 26 week endpoint in Neutrophil counts		Baseline, 26 weeks	Yes
Secondary	Change from baseline to 26 week endpoint in Lymphocyte subsets		Baseline, 26 weeks	Yes
Secondary	Pharmacokinetics - Area under the concentration-time curve (AUC)		Baseline, days 7, 14, 28, 42, 56, 70, 72, 74, 77, 80, 84, 98, 126 and 182	No
Secondary	Pharmacokinetics - Maximum plasma drug concentration (Cmax)		Baseline, days 7, 14, 28, 42, 56, 70, 72, 74, 77, 80, 84, 98, 126 and 182	No
Secondary	Pharmacokinetics - Time of maximum observed drug concentration		Baseline, days 7, 14, 28, 42, 56, 70, 72, 74, 77, 80, 84, 98, 126 and 182	No