Clinical trial NCT01970475: Efficacy and Safety Study of ABP 501 Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis, Rheumatoid
Keywords: Arthritis
Rheumatoid
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2013-10-28
Enrollment: 526
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effectiveness and safety of ABP 501 against adalimumab (HUMIRA®) in adults with moderate to severe rheumatoid arthritis (RA) who have an inadequate response to methotrexate (MTX).


Eligibility 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

Primary outcomes:
measure: Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 24
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Change From Baseline in Disease Activity Score 28-C-reactive Protein (DAS28-CRP)
timeFrame: Baseline and weeks 2, 4, 8, 12, 18, and 24
measure: Percentage of Participants With an ACR20 Response at Week 2 and Week 8
timeFrame: Baseline, week 2 and week 8
measure: Percentage of Participants With an ACR50 Response at Week 24
timeFrame: Baseline and week 24
measure: Percentage of Participants With an ACR70 Response at Week 24
timeFrame: Baseline and Week 24
measure: Number of Participants With Adverse Events
timeFrame: From the time of first treatment up to 28 days following the last dose of study treatment; 26 weeks.
measure: Percentage of Participants Who Developed Antibodies to ABP 501 or Adalimumab
timeFrame: Up to week 26
Other outcomes:
Locations:
city: Victorville
country: United States
facility: Research Site
state: California
city: Jupiter
country: United States
facility: Research Site
state: Florida
city: Sandy Springs
country: United States
facility: Research Site
state: Georgia
city: Lansing
country: United States
facility: Research Site
state: Michigan
city: Middleburg Heights
country: United States
facility: Research Site
state: Ohio
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: Hattingen
country: Germany
facility: Research Site
state: Nordrhein-westfalen
city: Barnsley
country: United Kingdom
facility: Research Site
state: England
city: North Shields
country: United Kingdom
facility: Research Site
state: England
city: Suffolk
country: United Kingdom
facility: Research Site
state: England
city: Cardiff
country: United Kingdom
facility: Research Site
state: Wales
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Huizinga TWJ, Torii Y, Muniz R. Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity. Rheumatol Ther. 2021 Mar;8(1):41-61. doi: 10.1007/s40744-020-00259-8. Epub 2020 Dec 1.
citation: Cohen S, Genovese MC, Choy E, Perez-Ruiz F, Matsumoto A, Pavelka K, Pablos JL, Rizzo W, Hrycaj P, Zhang N, Shergy W, Kaur P. Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study. Ann Rheum Dis. 2017 Oct;76(10):1679-1687. doi: 10.1136/annrheumdis-2016-210459. Epub 2017 Jun 5.