A Multiple Dose Study to Evaluate Subcutaneous AMG 108 in Subjects With Rheumatoid Arthritis

Amgen

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: AMG 108

Study type: Interventional

Funder types: Industry

Identifiers

NCT00293826

20050168

Details and patient eligibility

About

The purpose of this study is to determine if AMG 108 in combination with methotrexate is safe and effective in the treatment of rheumatoid arthritis.

Enrollment: 813 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with active rheumatoid arthritis as diagnosed by meeting ACR classification criteria for at least 6 months.
• Must be taking MTX consecutively for >/= 12 weeks and at a stable dose of methotrexate at 15-25 mg weekly for at least 4 weeks prior to screening

Exclusion criteria

• Receipt of commercial or experimental biologic therapies for the treatment of inflammatory disease
• Presence of serious infection
• Class IV rheumatoid arthritis
• Prior or current history of tuberculosis infection or exposure
• Any other DMARDs other than methotrexate within 6 weeks of screening
• Pregnant or nursing
• Receipt of live vaccines within 3 months
• Felty's syndrome

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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813 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

196 subjects

Treatment:

Drug: AMG 108

Drug: AMG 108

Drug: AMG 108

3

Experimental group

Description:

196 subjects

Treatment:

Drug: AMG 108

Drug: AMG 108

Drug: AMG 108

2

Experimental group

Description:

196 subjects

Treatment:

Drug: AMG 108

Drug: AMG 108

Drug: AMG 108

4

Placebo Comparator group

Description:

196 subjects

Treatment:

Drug: Placebo