Back to Search Results
Study Complete
Sponsor ID
20120262

Efficacy and Safety Study of ABP 501 Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis

Sponsor ID
20120262
Clinicaltrials.gov ID
NCT01970475
EUCTIS ID
N/A
EudraCT ID
2013-000525-31
Contact Us

Study Details

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).

Additional Study Details

Phase
Phase 3
Product
ABP 501
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
526
Additional Study Details

Protocol Summary

Primary Outcome Measures

The primary efficacy endpoint is ACR20 (20% improvement in ACR core set measurements) at week 24.

Timeframe: Week 24

Secondary Outcome Measures

Disease Activity Score 28-CRP

Timeframe: Week 24

ACR50 and ACR70 response

Timeframe: Week 24

Incidence of anti-drug antibodies

Timeframe: Week 26

Subject incidence of adverse events and serious adverse events

Timeframe: Week 26

Clinically significant changes in laboratory values and vital signs

Timeframe: Week 26

ACR20 response

Timeframe: Weeks 2 and 8

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)
Plain Language Summary of Results
Available Language(s): Polish, Romanian, Spanish, Russian, Spanish (Latin America), English, Bulgarian, French (Canadian), Czech, German, Hungarian
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Hattingen, NORDRHEIN-WESTFALEN, Germany, 45525
Status
Completed
Location
Research Site
Barnsley, England, United Kingdom, S75 2EP
Status
Completed
Location
Research Site
Cardiff, WALES, United Kingdom, CF14 4XN
Status
Completed
Location
Research Site
Jupiter, FL, United States, 33458
Status
Completed
Location
Research Site
Lansing, MI, United States, 48910
Status
Completed
Location
Research Site
Middleburg Heights, OH, United States, 44130
Status
Completed
Showing {first} - {last} of {total} Results
Study Info
Age
18 - 80 Years
Condition
  • Rheumatoid Arthritis
    • Sex
    All
    Trial Dates
    Oct 2013 - Nov 2014
    Inclusion and Exclusion 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