A Study for Japanese Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01253226
First received: December 1, 2010
Last updated: September 16, 2011
Last verified: September 2011
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
Drug: LY2127399
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

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 32 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics of LY2127399, area under the concentration time curve (AUC) [ Time Frame: Up to 32 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics of LY2127399, maximum concentration (Cmax) [ Time Frame: Up to 32 weeks ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Change from baseline in Anti-Cyclic Citrullinated Peptide antibody (anti-CCP) [ Time Frame: baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Rheumatoid Factor [ Time Frame: baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Immunoglobulins (IgG, IgM, IgA) [ Time Frame: baseline, 4, 16, 24 and 32 weeks. ] [ Designated as safety issue: No ]
  • Change from baseline in C- reactive protein [ Time Frame: baseline, 1, 4, 16, 24 and 32 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Erythrocyte Sedimentation Rate (ESR) [ Time Frame: baseline, 1, 4, 16, 24 and 32 weeks. ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: September 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01253226     History of Changes
Other Study ID Numbers: 13060, H9B-JE-BCDK
Study First Received: December 1, 2010
Last Updated: September 16, 2011
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 22, 2014