A Study of Japanese Rheumatoid Arthritis Patients
This study is ongoing, but not recruiting participants.
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01253291
First received: December 1, 2010
Last updated: September 20, 2012
Last verified: September 2012
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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 2013 |
| Estimated Primary Completion Date: | June 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: | September 20, 2012 |
| 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 22, 2013