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

Part of paid clinical trials in Bowling Green, Kentucky.

Sponsor
Pfizer
Study ID
NCT04230213
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • PF-06410293 — DRUG
    SC injection
  • adalimumab — DRUG
    SC injection

Study Details

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.

Key Dates

Start date
Jan 13, 2020
Status verified
Jan 2024
Primary completion
Jun 22, 2021
Completion
Jun 22, 2021

Study Design

Enrollment
455 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm 1
    Subcutaneous (SC) injection given every other week
  • Active Comparator: Treatment Arm 2
    SC injection given every other week

Primary Outcome Measure

Maximum Observed Serum Concentration (Cmax) of Adalimumab [ Time Frame: Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30) ]

Locations (4)

FacilityCityStateZIPSite coordinators
Graves Gilbert ClinicBowling GreenKentucky42101-
Altoona Center for Clinical ResearchDuncansvillePennsylvania16635-
Metroplex Clinical Research CenterDallasTexas75231-
Rheumatology and Pulmonary ClinicBeckleyWest Virginia25801-

Find similar trials in Bowling Green, KY

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Graves Gilbert Clinic· Bowling Green, KYAltoona Center for Clinical Research· Duncansville, PAMetroplex Clinical Research Center· Dallas, TXRheumatology and Pulmonary Clinic· Beckley, WV

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