A Comparative Study Between PF-06410293 and Humira® in Combination With Methotrexate in Participants With Active Rheumatoid Arthritis

Pfizer

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: PF-06410293; Drug: adalimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04230213

B5381012 (Other Identifier)

2019-000284-24 (EudraCT Number)

Details and patient eligibility

About

The study will assess the impact of pharmacokinetics (PK), safety and immunogenicity after switches between PF-06410293 and adalimumab and with continuous dosing with adalimumab in combination with methotrexate in subjects with moderately to severely active rheumatoid arthritis.

Enrollment: 455 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of RA based on 2010 ACR/EULAR for RA for at least a 4 month duration.
• Moderately to severely active RA based on local standard of care.

Exclusion criteria

-Evidence of untreated or inadequately treated latent or active TB.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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455 participants in 2 patient groups

Treatment Arm 1

Experimental group

Description:

Subcutaneous (SC) injection given every other week

Treatment:

Drug: adalimumab

Drug: PF-06410293

Treatment Arm 2

Active Comparator group

Description:

SC injection given every other week

Treatment:

Drug: adalimumab