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Study Complete
Sponsor ID
20050168

A Multiple Dose Study to Evaluate Subcutaneous AMG 108 in subjects with Rheumatoid Arthritis

Sponsor ID
20050168
Clinicaltrials.gov ID
NCT00293826
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 2
Product
AMG 108
Type
Interventional
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Enrollment
813
Additional Study Details

Protocol Summary

Primary Outcome Measures

ACR20 response

Timeframe: 24 Weeks

Secondary Outcome Measures

Change in subject reported outcomes

Timeframe: 24 Weeks

ACRn, AUC ACRn, ACR50, ACR70, and DAS28

Timeframe: 24 Weeks

PK parameters

Timeframe: 24 Weeks

Safety endpoints including AEs, SAEs, SIEs, and change in anti-AMG 108 antibody status

Timeframe: 24 Weeks

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

No locations found.
Study Info
Age
18 - 70 Years
Condition
  • Rheumatoid Arthritis
    • Sex
    All
    Trial Dates
    Mar 2006 - Nov 2007
    Inclusion and Exclusion Criteria
    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