A Study to Evaluate the Efficacy and Safety of CAM-3001 (Drug) in Subjects With Rheumatoid Arthritis

MedImmune

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Biological: Mavrilimumab 30 mg; Biological: Mavrilimumab 10 mg; Biological: Mavrilimumab 100 mg; Biological: Mavrilimumab 50 mg; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01050998

MI-CP219

Details and patient eligibility

About

The primary objectives of this study is to assess the safety, tolerability and efficacy of multiple doses of the mavrilimumab (CAM-3001) administered subcutaneously in subjects with moderately active Rheumatoid Arthritis (RA).

Full description

This is a Phase 2, randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the efficacy and safety of multiple doses of the mavrilimumab (CAM-3001) (10 milligram [mg], 30 mg, 50 mg, and 100 mg) administered subcutaneously in adult subjects with moderately active RA.

Enrollment: 516 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 through 80 years (20 to 75 years in Japan)
• Written consent
• Diagnosis of adult onset Rheumatoid Arthritis (RA) of at least 3 months duration as defined by the 1987 American College of Rheumatology (ACR) classification criteria (Arnett et al, 1988)
• Treatment with methotrexate at a stable and tolerated doses
• Positive anti-cyclic citrullinated peptide (CCP) immuno-globulin G antibodies (more than [>] 5 international unit per milliliter [IU/mL]) and/or rheumatoid factor (RF >14 IU/mL) at screening
• Received more than or equal to (>=) 5 milligram (mg) per week folic acid as a single or divided dose during the study.

Exclusion criteria

• A rheumatic autoimmune disease other than RA
• A history of, or current, inflammatory joint disease other than RA or other systemic autoimmune disorder
• Subjects at a high risk of infection
• Subjects (male and female) of reproductive potential who are not willing to use contraception from screening through the end date of the trial
• History of methotrexate or any drug-induced lung fibrosis or pneumonitis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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516 participants in 5 patient groups, including a placebo group

Mavrilimumab 10 mg

Experimental group

Description:

Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.

Treatment:

Biological: Mavrilimumab 10 mg

Mavrilimumab 30 mg

Experimental group

Description:

Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.

Treatment:

Biological: Mavrilimumab 30 mg

Mavrilimumab 50 mg

Experimental group

Description:

Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.

Treatment:

Biological: Mavrilimumab 50 mg

Mavrilimumab 100 mg

Experimental group

Description:

Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.

Treatment:

Biological: Mavrilimumab 100 mg

Placebo

Placebo Comparator group

Description:

Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.

Treatment:

Other: Placebo