A Study of Japanese Rheumatoid Arthritis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01253291
First received: December 1, 2010
Last updated: April 30, 2014
Last verified: April 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
Study Completion Date: March 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
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: 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: April 30, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 21, 2014