An Open Label Study for Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01215942
First received: October 5, 2010
Last updated: April 14, 2014
Last verified: March 2014
  Purpose

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

This study is comprised of 2 periods:

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

Period 2 - 48 week post treatment follow up


Condition Intervention Phase
Rheumatoid Arthritis
Drug: LY2127399
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Percentage of patients developing anti-LY2127399 antibodies [ Time Frame: Baseline through 240 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in absolute B cell counts [ Time Frame: Baseline through 240 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in serum immunoglobulin (Ig) levels [ Time Frame: Baseline through 240 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percentage of patients with American College of Rheumatology 20% (ACR20), 50% (ACR50) and 70% (ACR70) response [ Time Frame: Baseline through 240 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Disease Activity Score-C-Reactive Protein (DAS28-CRP) [ Time Frame: Baseline through 240 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with DAS28-Based European League Against Rheumatism (EULAR-28) response [ Time Frame: Baseline through 240 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) domain scores and summary scores [ Time Frame: Baseline through 240 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Tender Joint Count (68 joint count) [ Time Frame: Baseline through 240 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Swollen Joint Count (66 joint count) [ Time Frame: Baseline through 240 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Patient's Assessment of Pain (VAS) [ Time Frame: Baseline through 240 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Patient's Global Assessment of Disease Activity (VAS) [ Time Frame: Baseline through 240 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Physician's Global Assessment of Disease Activity (VAS) [ Time Frame: Baseline through 240 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Health Assessment Questionnaire-Disability Index HAQ-DI [ Time Frame: Baseline through 240 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in CRP [ Time Frame: Baseline through 240 weeks ] [ Designated as safety issue: No ]
  • Mean percent improvement in ACR-N [ Time Frame: Baseline through 240 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 1505
Study Start Date: June 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 120 mg of LY2127399

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

Or

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

Drug: LY2127399
Administered Subcutaneously
Experimental: 90 mg LY2127399

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

Or

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

Drug: LY2127399
Administered Subcutaneously

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completion of 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 symptoms of a serious disorder or illness
  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: NCT01215942

  Show 327 Study Locations
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 9AM - 5PM Eastern time (UCT/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01215942     History of Changes
Other Study ID Numbers: 13419, H9B-MC-BCDP
Study First Received: October 5, 2010
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Argentina: Ministry of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration
Brazil: National Health Surveillance Agency
Bulgaria: Bulgarian Drug Agency
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Croatia: Ministry of Health and Social Care
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Greece: Ministry of Health and Welfare
Hungary: National Institute of Pharmacy
India: Drugs Controller General of India
Italy: The Italian Medicines Agency
Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency
Lithuania: State Medicine Control Agency - Ministry of Health
Malaysia: Ministry of Health
Mexico: Secretaria de Salud
New Zealand: Medsafe
New Zealand: Ministry of Health
Peru: Instituto Nacional de Salud
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: The Central Register of Clinical Trials
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Russia: Pharmacological Committee, Ministry of Health
Slovakia: State Institute for Drug Control
Spain: Agencia Española de Medicamentos y Productos Sanitarios
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Sri Lanka: Ministry of Healthcare & Nutrition
Taiwan: Center for Drug Evaluation
Taiwan: Department of Health
Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by Eli Lilly and Company:
Rheumatoid Arthritis

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 October 16, 2014