NCT01970475

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
526

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_3

Geographic Reach
4 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 28, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

December 13, 2016

Completed
Last Updated

December 13, 2016

Status Verified

October 1, 2016

Enrollment Period

1.1 years

First QC Date

October 23, 2013

Results QC Date

October 20, 2016

Last Update Submit

October 20, 2016

Conditions

Arthritis, Rheumatoid

Keywords

ArthritisRheumatoid

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 24

    A participant was a responder if the following 3 criteria for improvement from Baseline were met: * ≥ 20% improvement in tender joint count; * ≥ 20% improvement in swollen joint count; and * ≥ 20% improvement in at least 3 of the 5 following parameters: * Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a likert scale from 0 to 10); * Physician's global assessment of disease activity (measured on a likert scale from 0 to 10); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]); * C-Reactive Protein level.

    Baseline and Week 24

Secondary Outcomes (6)

  • Change From Baseline in Disease Activity Score 28-C-reactive Protein (DAS28-CRP)

    Baseline and weeks 2, 4, 8, 12, 18, and 24

  • Percentage of Participants With an ACR20 Response at Week 2 and Week 8

    Baseline, week 2 and week 8

  • Percentage of Participants With an ACR50 Response at Week 24

    Baseline and week 24

  • Percentage of Participants With an ACR70 Response at Week 24

    Baseline and Week 24

  • Number of Participants With Adverse Events

    From the time of first treatment up to 28 days following the last dose of study treatment; 26 weeks.

  • +1 more secondary outcomes

Study Arms (2)

ABP 501

EXPERIMENTAL

Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.

Biological: ABP 501

Adalimumab

ACTIVE COMPARATOR

Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.

Biological: Adalimumab

Interventions

ABP 501BIOLOGICAL

Solution for subcutaneous injection in pre-filled syringe

Also known as: AMJEVITA™, Adalimumab-atto
ABP 501
AdalimumabBIOLOGICAL

Solution for subcutaneous injection in pre-filled syringe

Also known as: HUMIRA®
Adalimumab

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women ≥ 18 and ≤ 80 years old
  • Subjects must be diagnosed with rheumatoid arthritis for at least 3 months before baseline
  • Active RA defined as ≥ 6 swollen joints and ≥ 6 tender joints at screening and baseline
  • 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
  • Subject has no known history of active tuberculosis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Research Site

Victorville, California, 92395, United States

Location

Research Site

Jupiter, Florida, 33458, United States

Location

Research Site

Sandy Springs, Georgia, 30328, United States

Location

Research Site

Lansing, Michigan, 48910, United States

Location

Research Site

Middleburg Heights, Ohio, 44130, United States

Location

Research Site

Winnipeg, Manitoba, R3A 1M3, Canada

Location

Research Site

Hattingen, North Rhine-Westphalia, 45525, Germany

Location

Research Site

Barnsley, England, S75 2EP, United Kingdom

Location

Research Site

North Shields, England, NE29 8NH, United Kingdom

Location

Research Site

Suffolk, England, IP4 5PD, United Kingdom

Location

Research Site

Cardiff, Wales, CF14 4XN, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 33263165DERIVED

  • 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.

    PMID: 28584187DERIVED

Related Links

MeSH Terms

Conditions

Arthritis, RheumatoidArthritis

Interventions

ABP 501Adalimumab

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Study Director
Organization
Amgen Inc.
866-572-6436

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2013

First Posted

October 28, 2013

Study Start

October 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

December 13, 2016

Results First Posted

December 13, 2016

Record last verified: 2016-10

Locations

US(5)CA(1)GB(4)DE(1)