A Study of Japanese Rheumatoid Arthritis Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01253291
First received: December 1, 2010
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

The objective of this study is to evaluate the safety and tolerability of 48 weeks subcutaneous dosing with LY2127399 for patients who have participated in a prior LY2127399 clinical study. At the end of the 48 week treatment period, patients will participate in a 24 week follow up period. Additional follow up after week 72 may continue to assess B cell recovery.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: LY2127399
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Extension Study of Multiple Subcutaneous Doses 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 Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: up to 72 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in Anti-Cyclic Citrullinated Peptide antibody (anti-CCP) [ Time Frame: baseline, 12weeks, 24weeks, 36weeks, 52 weeks, 72weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Rheumatoid Factor [ Time Frame: baseline, 12weeks, 24weeks, 36weeks, 52 weeks, 72weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Immunoglobulins (IgG, IgM, and IgA) [ Time Frame: baseline, 12weeks, 24weeks, 36weeks, 52 weeks, 72weeks ] [ Designated as safety issue: No ]
  • Change from baseline in CD20+ B cells [ Time Frame: baseline, 12weeks, 24weeks, 36weeks, 52 weeks, 72weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Peripheral B cell subsets [ Time Frame: baseline, 12weeks, 24weeks, 36weeks, 52 weeks, 72weeks ] [ Designated as safety issue: No ]
  • Change from baseline in C-reactive protein [ Time Frame: baseline, 12weeks, 24weeks, 36weeks, 52 weeks, 72weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Erythrocyte sedimentation rate (ESR) [ Time Frame: baseline, 12weeks, 24weeks, 36weeks, 52 weeks, 72weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: May 2010
Estimated Study Completion Date: June 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 30mg/120 mg LY2127399
Subjects in the 30 mg every 4 weeks arm of lead in study will receive 30 mg every four weeks until the safety of the 120 mg every 4 weeks dose is confirmed in the lead in study.
Drug: LY2127399
Administered subcutaneously every 4 weeks for 48 weeks
Experimental: 120 mg LY2127399
Subjects in the 60 mg every 4 weeks, 120 mg every 4 weeks and 120 mg every 2 weeks arms of the lead in study will receive 120 mg every 4 weeks as these patients will enroll in this study after the safety of the 120 mg every 4 weeks dose in the lead in study is confirmed.
Drug: LY2127399
Administered subcutaneously every 4 weeks for 48 weeks

  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
  • Must have completed treatment and 12 week follow up period in prior LY2127399 study

Exclusion criteria

  • Have had any safety event during the study for LY2127399 that patients participated in previous
  • Have received, during previous study, any drugs prohibited in the study protocol which includes unapproved drugs, live vaccines, or any biologic or non-biologic DMARD except for MTX, hydroxychloroquine, sulfasalazine or bucillamine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01253291

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, 460-0001
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, 2892511
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, 910-0067
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, 370-0053
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, 311-3516
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, 252-0392
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, 982-0032
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, 152-8902
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: NCT01253291     History of Changes
Other Study ID Numbers: 13417, H9B-JE-BCDL
Study First Received: December 1, 2010
Last Updated: January 21, 2014
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 April 22, 2014