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Study Complete
Sponsor ID
20070264

Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis

Sponsor ID
20070264
Clinicaltrials.gov ID
NCT00771030
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

This Phase 1b/2a study will evaluate safety, tolerability PK and PD of AMG 827 when administered in multiple SC and IV doses in patients with active rheumatoid arthritis in combination with a stable dose of DMARDs. Part A is dose escalation (to assess safety & tolerability), and Part B is dose expansion (to assess clinical efficacy) at the highest tolerated dose level of AMG 827 from Part A.

Additional Study Details

Phase
Phase 1/Phase 2
Product
AMG 827
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
40
Additional Study Details

Protocol Summary

Primary Outcome Measures

Part B:Primary efficacy outcome is the bdACR Hybrid response in active or placebo groups

Timeframe: 12 weeks

Secondary Outcome Measures

Safety & tolerability: 1. treatment-emergent AE(s) 2. clinically significant changes in safety labs, PE, vital signs and 3. development of anti-AMG 827 antibodies.

Timeframe: 18 weeks

Study Documents

Study Synopsis
Available Language(s): English
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Locations

No locations found.
Study Info
Age
18 - 70 Years
Condition
  • Rheumatoid Arthritis
    • Sex
    All
    Trial Dates
    Nov 2008 - May 2010
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Male or female between 18 to 70 years of age, inclusive at the time of screening - Diagnosed with active RA (class 1-3) for at least 6 months as determined by meeting ACR 1987 revised classification criteria. - Additional Inclusion Criteria Apply
    Exclusion Criteria:
    - History or evidence of a clinically significant disorder other than RA (including but not limited to cardiopulmonary, oncologic, renal, metabolic, hematologic or psychiatric), condition or disease that, in the opinion of the Investigator and Amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures or completion - Uncontrolled, clinically significant systemic disease other than RA such as diabetes mellitus, liver disease, asthma, cardiovascular disease or hypertension - Malignancy within 5 years (except successfully treated in situ cervical cancer or squamous or basal cell carcinoma of the skin) - Presence of a serious or chronic infections - Subject (male or female) is not willing to use highly effective contraception, defined as a double barrier method (ie, spermicidal jelly and condom, or condom and diaphragm) during treatment and up to EOS - Additional Exclusion Criteria Apply