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Completed

NCT Number: NCT01253291

A Study of Japanese Rheumatoid Arthritis Participants

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 NCT01253226 [Study H9B-JE-BCDK (BCDK)]

Exclusion criteria

  • Have had any safety event during the previous LY2127399 (BCDK) study that participants participated in
  • Have received, during previous study (BCDK), any drugs prohibited in the study protocol which includes unapproved drugs, live vaccines, or any biologic or non-biologic disease-modifying anti-rheumatic drug (DMARD) except for, methotrexate (MTX), hydroxychloroquine, sulfasalazine or bucillamine

Treatment and study plan

LY2127399

Drug

Administered subcutaneously every 4 weeks for 48 weeks

Other names: tabalumab

Primary outcomes

  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: Baseline up to 72 weeks

    Included are the number of participants who experienced SAEs and treatment-emergent other non-SAEs. A summary of SAEs and other non-SAEs, regardless of causality, is located in the Reported Adverse Events (AEs) module.

Secondary outcomes

  1. Percent Change From Baseline in Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody

    Time frame: Baseline and Weeks 12, 24, 36, 52, and 72

    Anti-CCP is a disease related peripheral blood biomarker used to assess disease progression of rheumatoid arthritis (RA). A reduction in anti-CCP values indicates an improvement.

  2. Percent Change From Baseline in Rheumatoid Factor (RF)

    Time frame: Baseline and Weeks 12, 24, 36, 52, and 72

    RF is a disease-related, peripheral blood biomarker used to assess disease progression of RA. A reduction in RF values indicate an improvement in RA symptoms.

  3. Percent Change From Baseline in Immunoglobulins [Immunoglobulin (Ig) G, IgM, and IgA]

    Time frame: Baseline and Weeks 12, 24, 36, 52, and 72

    IgG, IgM and IgA are disease related peripheral blood biomarkers used to assess disease progression of RA. A reduction in Ig values indicate an improvement in RA symptoms.

  4. Percent Change From Baseline in CD20+ B-cell Count

    Time frame: Baseline and Weeks 12, 24, 36, 52, and 72

    CD20+ B-cells are a disease-related peripheral blood biomarker used to assess disease progression of RA. A reduction in CD20+ B-cell values indicate an improvement in RA symptoms.

  5. Percent Change From Baseline in Peripheral B-cell Subsets

    Time frame: Baseline and Weeks 12, 24, 36, 52, and 72

    Peripheral B cell subsets (Mature Naive B-cells and Switched Memory B cells) are disease-related peripheral blood biomarkers used to assess disease progression of RA. A reduction in cell values indicate an improvement in RA symptoms.

  6. Percent Change From Baseline in C-Reactive Protein (CRP)

    Time frame: Baseline and Weeks 12, 24, 36, 52, and 72

    CRP is a disease-related peripheral blood biomarker used to assess disease progression of RA. A reduction in CRP values indicate an improvement in RA symptoms.

  7. Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)

    Time frame: Baseline and Weeks 12, 24, 36, 52, and 72

    ESR is a disease related peripheral blood biomarker used to assess, in part, the effect of LY2127399 on the participants' RA disease progression. A reduction in ESR values indicate an improvement in RA symptoms.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399 in Japanese Patients With Rheumatoid Arthritis Treated With Methotrexate

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Dec 3, 2010
Registry last updated
Mar 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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