Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00771030
Recruitment Status : Completed
First Posted : October 10, 2008
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE October 9, 2008
First Posted Date  ICMJE October 10, 2008
Last Update Posted Date November 1, 2016
Study Start Date  ICMJE November 2008
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2008)
Part B:Primary efficacy outcome is the bdACR Hybrid response in active or placebo groups [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00771030 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2010)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2008)
Safety & tolerabilty: 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 827 in Subjects With Rheumatoid Arthritis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: AMG 827
    Five treatment dose levels in Part A with AMG 827 and one dose level in Part B with AMG 827
  • Other: Placebo
    Five treatment dose levels in Part A with placebo and one dose level in Part B with placebo
Study Arms  ICMJE
  • 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

    Intervention: Drug: 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

    Intervention: Other: Placebo
Publications * Martin DA, Churchill M, Flores-Suarez L, Cardiel MH, Wallace D, Martin R, Phillips K, Kaine JL, Dong H, Salinger D, Stevens E, Russell CB, Chung JB. A phase Ib multiple ascending dose study evaluating safety, pharmacokinetics, and early clinical response of brodalumab, a human anti-IL-17R antibody, in methotrexate-resistant rheumatoid arthritis. Arthritis Res Ther. 2013 Oct 25;15(5):R164. doi: 10.1186/ar4347.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 18, 2010)
40
Original Estimated Enrollment  ICMJE
 (submitted: October 9, 2008)
94
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Canada,   Mexico,   United States
 
Administrative Information
NCT Number  ICMJE NCT00771030
Other Study ID Numbers  ICMJE 20070264
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP