A Rheumatoid Arthritis (RA) Study Treating Signs and Symptoms of RA in People With RA & Receiving Methotrexate

Amgen

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: AGM 719; Drug: AMG 719; Drug: placebo to AMG 719

Study type: Interventional

Funder types: Industry

Identifiers

NCT00038298

20010238

Details and patient eligibility

About

This clinical study is investigating AMG 719, an investigational drug, for the treatment of patients who have Rheumatoid Arthritis and who are taking Methotrexate. AMG 719 is a drug which is self-injected beneath the skin (similarly to the way insulin is self-injected by diabetics). Patients on this study are on study for 28-weeks. They visit the study facility at least 11 times while participating in the study.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Men or women, at least 18 years of age at screening
• Diagnosed with Rheumatoid Arthritis, with a disease duration of at least 24 weeks, receiving methotrexate, and having no recent history of substance or alcohol abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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53 participants in 4 patient groups, including a placebo group

50 mg

Experimental group

Description:

50 mg 3 times weekly

Treatment:

Drug: AMG 719

Drug: AMG 719

400 mg

Experimental group

Description:

400 mg 3 times weekly

Treatment:

Drug: AMG 719

Drug: AMG 719

200 mg

Experimental group

Description:

200 mg 3 times weekly

Treatment:

Drug: AGM 719

Placebo

Placebo Comparator group

Description:

Placebo comparator associated with each active arm. (3:1 active vs placebo)

Treatment:

Drug: Placebo

Drug: placebo to AMG 719