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Trial record 3 of 3 for:    amg 827 | "Rheumatic Diseases"

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

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ClinicalTrials.gov Identifier: NCT00771030
Recruitment Status : Completed
First Posted : October 10, 2008
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: AMG 827 Other: Placebo Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Ascending Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 827 in Subjects With Rheumatoid Arthritis
Study Start Date : November 2008
Primary Completion Date : May 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Rheumatoid Arthritis

The arm will enroll sequentially in two parts:

Part A - Dose escalation at different dose levels with AMG 827 Part B - Dose expansion at selected dose level from part 1 with AMG 827

Drug: AMG 827
Five treatment dose levels in Part A with AMG 827 and one dose level in Part B with AMG 827
Placebo Comparator: Rheumatoid Arthritis (Placebo)

The arm will enroll sequentially in two parts:

Part A - Dose escalation at different dose levels with placebo Part B - Dose expansion at selected dose level from part 1 with placebo

Other: Placebo
Five treatment dose levels in Part A with placebo and one dose level in Part B with placebo


Outcome Measures

Primary Outcome Measures :
  1. Part B:Primary efficacy outcome is the bdACR Hybrid response in active or placebo groups [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 18 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00771030


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00771030     History of Changes
Other Study ID Numbers: 20070264
First Posted: October 10, 2008    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases