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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
History of Changes
  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:

U.S. FDA Resources

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
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 May 23, 2013