Long-term Safety and Efficacy of ABP 501 in Subjects With Moderate to Severe Rheumatoid Arthritis

Amgen

Status and phase: Completed; Phase 3

Conditions: Arthritis, Rheumatoid

Treatments: Biological: ABP 501

Study type: Interventional

Funder types: Industry

Identifiers

NCT02114931

20130258

2013-004654-13 (EudraCT Number)

Details and patient eligibility

About

The purpose of this open-label study is to evaluate the long-term safety and efficacy of ABP 501 in adults with moderate to severe rheumatoid arthritis (RA).

Enrollment: 467 patients

Sex: All

Ages: 18 to 81 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject was randomized into protocol 20120262 (NCT01970475) and completed the week 26 visit

Exclusion criteria

• Subject experienced a serious adverse event (SAE) or an adverse event (AE) in the 20120262 study that could cause extension treatment to be detrimental
• Subject completed study 20120262 but cannot be dosed within 4 weeks of the week 26 visit of study 20120262
• Current infection requiring the use of oral or intravenous antibiotics

Other Inclusion/Exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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467 participants in 1 patient group

ABP 501

Experimental group

Description:

Participants received ABP 501 40 mg subcutaneously (SC) every other week for up to 18 months.

Treatment:

Biological: ABP 501