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

Rheumatoid Arthritis Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects With Rheumatoid Arthritis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00293826
• Other study ID #: 20050168
• Status: Completed
• Phase: Phase 2
• First received: February 17, 2006
• Last updated: March 4, 2010
• Start date: March 2006
• Est. completion date: February 2008

Study information

• Verified date: March 2010
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 813
• Est. completion date: February 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• AMG 108
50mg via SC (subcutaneous) injection every 4 weeks
• AMG 108
250mg via SC (subcutaneous) injection every 4 weeks
• AMG 108
125mg via SC (subcutaneous) injection every 4 weeks
• Placebo
Placebo via SC (subcutaneous) injection every 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ACR20 response		24 Weeks	No
Secondary	Change in subject reported outcomes		24 Weeks	No
Secondary	ACRn, AUC ACRn, ACR50, ACR70, and DAS28		24 Weeks	No
Secondary	PK parameters		24 Weeks	No
Secondary	Safety endpoints including AEs, SAEs, SIEs, and change in anti-AMG 108 antibody status		24 Weeks	Yes

External Links

•   AmgenTrials clinical trials website