Phase I Study Of The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenously Administered Doses Of PF-04236921 In Patients With Rheumatoid Arthritis

Pfizer

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: dose level 1; Drug: dose level 2; Drug: Placebo; Drug: dose level 3; Drug: dose level 4

Study type: Interventional

Funder types: Industry

Identifiers

NCT00838565

B0151002

2009-009866-15 (EudraCT Number)

Details and patient eligibility

About

This study will evaluate the safety and tolerability of PF-04236921 administered monthly as three intravenous infusions. Each group of patients will be assigned to a dose level; Safety and tolerability of a low dose level will be required before proceeding to successively higher dose levels. Blood tests will be performed to measure the amount of drug and changes in measures of inflammation.

Full description

Safety and Tolerability and Pharmacokinetic/Pharmacodynamic assessment of inflammation-related biomarkers.

Enrollment: 41 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Rheumatoid Arthritis on a stable dose of methotrexate
• Rheumatoid Arthritis disease activity as assessed by blood tests

Exclusion criteria

• Serious or uncontrolled medical conditions
• Current or recent treatment with disease-modifying drugs other than methotrexate including but not limited to leflunomide, sulfasalazine, etanercept, infliximab, adalimumab, abatacept, rituximab
• Current oral glucocorticoid dose of more than 10 mg/d prednisone equivalent

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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41 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

PF-04236921

Experimental group

Treatment:

Drug: dose level 1

Drug: dose level 3

Drug: dose level 4

Drug: dose level 2