Study to Assess if ABP 798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis (RA) Compared to Rituximab

Amgen

Status and phase: Completed; Phase 3

Conditions: Arthritis, Rheumatoid

Treatments: Drug: ABP 798; Drug: Rituximab (US); Drug: Rituximab (EU)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02792699

2013-005543-90 (EudraCT Number)

20130108

Details and patient eligibility

About

This trial is designed to determine what effects the human body has on the investigational medicine, ABP 798, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe RA.

This study will also assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.

Enrollment: 311 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men or women ≥ 18 and ≤ 80 years old

• Subjects must be diagnosed with rheumatoid arthritis for at least 6 months before baseline

• Active RA defined as ≥ 6 swollen joints and ≥ 6 tender joints at screening and baseline and at least one of the following at screening:

  • erythrocyte sedimentation rate (ESR) ≥ 28 mm/hr
  • serum C-reactive protein (CRP) > 1.0 mg/dL

• Subjects must be taking methotrexate (MTX) for ≥ 12 consecutive weeks and on a stable dose of MTX 7.5 to 25 mg/week for ≥ 8 weeks prior to receiving the investigational product (IP), and be willing to remain on a stable dose throughout the study

• Subject has no known history of active tuberculosis

Exclusion criteria

• 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

• Use of commercially available or investigational biologic therapies for RA as follows:

  • anakinra, etanercept within 1 month prior to first dose of IP
  • infliximab, abatacept, tocilizumab, golimumab, certolizumab within 3 months prior to first dose of IP
  • other experimental or commercially available biologic therapies for RA within 3 months or 5 half-lives (whichever is longer) prior to first dose of IP

• Previous receipt of rituximab or a biosimilar of rituximab

Other Inclusion/Exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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311 participants in 3 patient groups

ABP 798 / ABP 798

Experimental group

Description:

Participants received ABP 798 on days 1 and 15 (dose 1) and a second dose of ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.

Treatment:

Drug: ABP 798

Rituximab (US) / ABP 798

Active Comparator group

Description:

Participants received rituximab (United States \[US\] formulation) on days 1 and 15 (dose 1) and transitioned to receive ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.

Treatment:

Drug: ABP 798

Drug: Rituximab (US)

Rituximab (EU) / Rituximab (EU)

Active Comparator group

Description:

Participants received rituximab (European Union \[EU\] formulation) on days 1 and 15 (dose 1) and a second dose of rituximab (EU formulation) at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.

Treatment:

Drug: Rituximab (EU)