Efficacy and Safety Study of ABP 501 Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis (RA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01970475
First received: October 23, 2013
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to compare the effectiveness and safety of ABP 501 against Adalimumab (Humira®) in adult subjects with moderate to severe rheumatoid arthritis (RA) who have an inadequate response to methotrexate (MTX).


Condition Intervention Phase
Arthritis, Rheumatoid
Drug: ABP 501
Drug: Adalimumab (Humira®)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • The primary efficacy endpoint is ACR20 (20% improvement in ACR core set measurements) at week 24. [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    20% improvement in ACR (American College of Rheumatology) core set measurements


Secondary Outcome Measures:
  • Disease Activity Score 28-CRP [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • ACR50 and ACR70 response [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    50% or 70% improvement in ACR core set measurements

  • Incidence of anti-drug antibodies [ Time Frame: Week 26 ] [ Designated as safety issue: Yes ]
  • Subject incidence of adverse events and serious adverse events [ Time Frame: Week 26 ] [ Designated as safety issue: Yes ]
  • Clinically significant changes in laboratory values and vital signs [ Time Frame: Week 26 ] [ Designated as safety issue: Yes ]
  • ACR20 response [ Time Frame: Weeks 2 and 8 ] [ Designated as safety issue: No ]
    20% improvement in ACR core set measurements


Enrollment: 526
Study Start Date: October 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABP 501
Solution for subcutaneous injection in pre-filled syringe administered in a dose of 40 mg every 2 weeks for 22 weeks.
Drug: ABP 501
Active Comparator: Adalimumab (Humira®)
Solution for subcutaneous injection in pre-filled syringe administered in a dose of 40 mg every 2 weeks for 22 weeks.
Drug: Adalimumab (Humira®)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men or women ≥ 18 and ≤ 80 years old
  2. Subjects must be diagnosed with Rheumatoid Arthritis for at least 3 months before baseline
  3. Active RA defined as ≥ 6 swollen joints and ≥ 6 tender joints at screening and baseline
  4. Subjects must be taking MTX for ≥ 12 consecutive weeks and on a stable dose of 7.5 to 25 mg/week for > 8 weeks prior to receiving the study drug and be willing to remain on stable dose throughout the study
  5. Subject has no known history of active tuberculosis

Exclusion Criteria:

  1. Class IV RA, Felty's syndrome or history of prosthetic or native joint infection
  2. Major chronic inflammatory disease or connective tissue disease other than RA, with the exception of secondary Sjögren's syndrome
  3. Prior use of 2 or more biologic therapies for RA
  4. Previous receipt of Humira® (adalimumab) or a biosimilar of adalimumab
  5. Ongoing use of prohibited treatments

Other Inclusion/Exclusion criteria may apply

  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: NCT01970475

  Show 111 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01970475     History of Changes
Other Study ID Numbers: 20120262, 2013-000525-31
Study First Received: October 23, 2013
Last Updated: June 3, 2014
Health Authority: Argentina: Ministry of Health
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Bulgaria: Ministry of Health
Canada: Ethics Review Committee
Canada: Health Canada
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Germany: Ethics Commission
Germany: Paul-Ehrlich-Institut
Hungary: Institutional Ethics Committee
Hungary: National Institute of Pharmacy
Mexico: Ethics Committee
Mexico: Ministry of Health
Poland: Ethics Committee
Poland: Ministry of Health
Romania: Ethics Committee
Romania: National Medicines Agency
Russia: Ethics Committee
Russia: Pharmacological Committee, Ministry of Health
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Amgen:
Arthritis
Rheumatoid

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 22, 2014