Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 94 of 2724 for:    Rheumatoid Arthritis

An Open Label Study for Participants With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01215942
Recruitment Status : Terminated (Insufficient efficacy observed in study BCDM (NCT01198002) and BCDV (NCT01202773).)
First Posted : October 7, 2010
Results First Posted : June 11, 2018
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:

The primary purpose of this study is to help answer if LY2127399 is safe and effective during long-term treatment in participants with Rheumatoid Arthritis.

This study is comprised of 2 periods:

Period 1: Unblinded treatment for up to 240 weeks for participants who enroll from Study H9B-MC-BCDO (BCDO) (NCT01202760) or Study H9B-MC-BCDV (BCDV) (NCT01202773) or up to 168 weeks for participants who enroll from Study H9B-MC-BCDM (BCDM) (NCT01198002).

Period 2: 48-week post-treatment follow-up


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: LY2127399 Phase 3

Detailed Description:
Week 16 non-responders (NR) are participants with <20% improvement from baseline in both tender and swollen joint counts when assessed at Week 16 of Studies BCDO, BCDV and BCDM.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1086 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA)
Study Start Date : June 2011
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 120 milligrams (mg) of LY2127399

Given every 4 weeks for 240 weeks for those participants from Study BCDO or Study BCDV. Participants who had been receiving placebo immediately prior to enrollment will receive a 240 mg loading dose when initiating treatment.

Or

Given every 4 weeks for 168 weeks for those participants from Study BCDM.

Drug: LY2127399
Administered Subcutaneously
Other Name: Tabalumab

Experimental: 90 mg LY2127399

Given every 2 weeks for 240 weeks for those participants from Study BCDO or Study BCDV. Participants who had been receiving placebo immediately prior to enrollment will receive a 180 mg loading dose when initiating treatment.

Or

Given every 2 weeks for 168 weeks for those participants from Study BCDM.

Drug: LY2127399
Administered Subcutaneously
Other Name: Tabalumab




Primary Outcome Measures :
  1. Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESI)During Treatment Period [ Time Frame: up to 84.4 weeks during treatment period ]
    A TEAE was defined as an event that first occurred or worsened in severity on or after the date of the first injection and prior to study termination. AESI are infection, injection site reactions, malignancy, major adverse cardiovascular events (MACE), allergy and hypersensitivity, depression, suicide/self-injury and pregnancy. MACE were defined as 1 of the adjudicated events: cardiovascular death, Myocardial infarction (MI), stroke, hospitalization for unstable angina, hospitalization for heart failure, coronary revascularization procedure, peripheral revascularization procedure, cardiogenic shock due to MI, resuscitated sudden death, serious arrhythmia, hospitalization for hypertension, peripheral arterial event. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.

  2. Percentage of Participants Developing Anti-LY2127399 Antibodies [ Time Frame: Baseline through Weeks 4, 24, 48 and 72 ]
    Participants with treatment-emergent anti-LY2127399 antibodies were participants who had any samples from baseline up to and through Week 72 that was a 4-fold increase (2-dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Baseline is defined as the last non-missing observation on or prior to the date of the first injection of LY2127399 in preceding studies or Study BCDP. Percentage of participants with anti-LY2127399 antibodies=(number of participants with treatment-emergent anti-LY2127399 antibodies / number of participants assessed)*100.

  3. Change From Baseline in Absolute B Cell Counts [ Time Frame: Baseline, Week 48 ]
    Cell-surface marker cluster designation (CD) 3 negative, CD20 positive (CD3-CD20+) defines total mature B cells. B-lymphocyte antigen CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells. Baseline B cell count is the average of the values on or prior to the date of first injection of study treatment in preceding studies, including unscheduled visits. A positive or negative change indicated an increase or decrease, respectively, in B cell count.

  4. Change From Baseline in Serum Immunoglobulin (Ig) Levels [ Time Frame: Baseline, Week 48 ]
    Immunoglobulins (Ig), or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline serum immunoglobulin A (IgA), immunoglobulin G (IgG), and immunoglobulin M (IgM) levels are reported. A negative change indicated a decrease in Ig levels. Baseline is defined as the last non-missing observation on or prior to the date of the first injection of LY2127399 in preceding studies or Study BCDP.


Secondary Outcome Measures :
  1. Percentage of Participants With American College of Rheumatology 20% Response (ACR20) [ Time Frame: Baseline through Weeks 12, 24 and 48 ]
    ACR Responder Index is a Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responders: had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). Baseline is defined as the last non-missing observation on or prior to the date of the first injection of LY2127399 in preceding studies or Study BCDP. Percentage of participants achieving ACR20 response=(number of ACR20 responders / number of participants treated) * 100. All participants who discontinue study treatment for any reason were defined as NR at that time point and going forward.

  2. Change From Baseline in Disease Activity Score Based on 28 Joint Count and C-Reactive Protein Level (DAS28-CRP) [ Time Frame: Baseline, 240 weeks ]
  3. Percentage of Participants With DAS28-Based European League Against Rheumatism (EULAR-28) Response [ Time Frame: Baseline through 240 weeks ]
  4. Change From Baseline in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain Scores and Summary Scores [ Time Frame: Baseline, 240 weeks ]
  5. Change From Baseline in Tender Joint Count (68 Joint Count) [ Time Frame: Baseline, 240 weeks ]
  6. Change From Baseline in Swollen Joint Count (66 Joint Count) [ Time Frame: Baseline, 240 weeks ]
  7. Change From Baseline in Participant's Assessment of Pain [Visual Analog Scale (VAS)] [ Time Frame: Baseline, 240 weeks ]
  8. Change From Baseline in Participants Global Assessment of Disease Activity (VAS) [ Time Frame: Baseline, 240 weeks ]
  9. Change From Baseline in Physicians Global Assessment of Disease Activity (VAS) [ Time Frame: Baseline, 240 weeks ]
  10. Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: Baseline, 240 weeks ]
  11. Change From Baseline in CRP [ Time Frame: Baseline, 240 weeks ]
  12. American College of Rheumatology Percent Improvement (ACR-N) [ Time Frame: Baseline through 240 weeks ]

Other Outcome Measures:
  1. Number of Participants Who Died During Treatment Period and Post-Treatment Follow-Up Period [ Time Frame: Up to 84.4 weeks during treatment period and discontinuation from study treatment up to 48 weeks during follow-up period ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have completed 24 weeks of participation in Study H9B-MC-BCDO or Study H9B-MC-BCDV, or have completed 100 weeks of participation in Study H9B-MC-BCDM
  • Woman must not be pregnant, breastfeeding, or become pregnant during the study

Exclusion Criteria:

  • Current presence of a serious disorder or illness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01215942


  Show 327 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Layout table for investigator information
Study Director: Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UCT/GMT - 5 hours, EST) Eli Lilly and Company

Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01215942     History of Changes
Other Study ID Numbers: 13419
H9B-MC-BCDP ( Other Identifier: Eli Lilly and Company )
First Posted: October 7, 2010    Key Record Dates
Results First Posted: June 11, 2018
Last Update Posted: June 11, 2018
Last Verified: May 2018

Keywords provided by Eli Lilly and Company:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs