We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study for Japanese Patients With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01253226
Recruitment Status : Completed
First Posted : December 3, 2010
Last Update Posted : September 20, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will evaluate the safety and tolerability of multiple doses of LY2127399 in Japanese patients with rheumatoid arthritis (RA).The study consists of a 20 week treatment period. All subjects will be followed up for 12 weeks after the last study drug administration.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: LY2127399 Drug: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multiple-Dose, Dose-Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY2127399 in Japanese Patients With Rheumatoid Arthritis Treated With Methotrexate
Study Start Date : September 2009
Primary Completion Date : August 2011
Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 30 mg LY2127399
30 mg LY2127399 every 4 weeks for 20 weeks (6 doses of study drug)
Drug: LY2127399
Administered subcutaneously
Experimental: 60 mg LY2127399
60 mg LY2127399 every 4 weeks for 20 weeks (6 doses of study drug)
Drug: LY2127399
Administered subcutaneously
Experimental: 120 mg LY2127399
120 mg LY2127399 every 4 weeks for 20 weeks (6 doses of study drug)
Drug: LY2127399
Administered subcutaneously
Placebo Comparator: Placebo every 4 weeks
every 4 weeks for 20 weeks
Drug: Placebo
Administered subcutaneously
Experimental: 120mg Q2W LY2127399
Initial loading dose of 240 mg LY2127399 followed by 120 mg every 2 weeks for 20 weeks (10 doses of study drug)
Drug: LY2127399
Administered subcutaneously
Placebo Comparator: Placebo every 2 weeks
every 2 weeks for 20 weeks
Drug: Placebo
Administered subcutaneously


Outcome Measures

Primary Outcome Measures :
  1. Number of participants with clinically significant effects [ Time Frame: Up to 32 weeks ]

Secondary Outcome Measures :
  1. Pharmacokinetics of LY2127399, area under the concentration time curve (AUC) [ Time Frame: Up to 32 weeks ]
  2. Pharmacokinetics of LY2127399, maximum concentration (Cmax) [ Time Frame: Up to 32 weeks ]
  3. Change from baseline in CD20+ B cell counts [ Time Frame: baseline, day2, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 and 32 weeks. ]
  4. Change from baseline in Anti-Cyclic Citrullinated Peptide antibody (anti-CCP) [ Time Frame: baseline, 24 weeks ]
  5. Change from baseline in Rheumatoid Factor [ Time Frame: baseline, 24 weeks ]
  6. Change from baseline in Immunoglobulins (IgG, IgM, IgA) [ Time Frame: baseline, 4, 16, 24 and 32 weeks. ]
  7. Change from baseline in C- reactive protein [ Time Frame: baseline, 1, 4, 16, 24 and 32 weeks ]
  8. Change from baseline in Erythrocyte Sedimentation Rate (ESR) [ Time Frame: baseline, 1, 4, 16, 24 and 32 weeks. ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have given written informed consent
  • Women must not be pregnant, breastfeeding or be at risk to become pregnant during study participation
  • Diagnosis of Rheumatoid Arthritis
  • Active Rheumatoid Arthritis
  • Current, regular use of Methotrexate, at a stable dose
  • Body weight between 40 and 105 kg, inclusive

Exclusion Criteria:

  • Use of excluded medications (reviewed by study doctor)
  • Have medical findings which, in the opinion of the study doctor, put patient at an unacceptable risk for participation in the study
  • Have had recent or ongoing infection which, in the opinion of the study doctor put patient at an unacceptable risk for participation
  • Evidence of tuberculosis
  • Have systemic inflammatory condition other than RA
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01253226


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.
Aichi, 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.
Chiba, 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.
Fukui, 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.
Gunma, 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.
Kanagawa, 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.
Miyagi, 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.
Osaka, 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, Japan
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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01253226     History of Changes
Other Study ID Numbers: 13060
H9B-JE-BCDK ( Other Identifier: Eli Lilly and Company )
First Posted: December 3, 2010    Key Record Dates
Last Update Posted: September 20, 2011
Last Verified: September 2011

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs