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

Amgen

Status and phase: Completed; Phase 3

Conditions: Arthritis, Rheumatoid

Treatments: Biological: Adalimumab; Biological: ABP 501

Study type: Interventional

Funder types: Industry

Identifiers

NCT01970475

20120262

2013-000525-31 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 526 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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526 participants in 2 patient groups

ABP 501

Experimental group

Description:

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

Treatment:

Biological: ABP 501

Adalimumab

Active Comparator group

Description:

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

Treatment:

Biological: Adalimumab