Assess Safety, Tolerability, Pharmacokinetics and Clinical Activity of AMP-110 in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

A Randomized, Multi-Dose, Placebo-Controlled, Study of the Safety, Tolerability, Pharmacokinetics and Clinical Activity of AMP-110 in Subjects With Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02277574
• Other study ID #: AMP-110-02
• Status: Completed
• Phase: Phase 1
• First received: July 23, 2014
• Last updated: November 17, 2016
• Start date: June 2014
• Est. completion date: July 2015

Study information

• Verified date: November 2016
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a Phase 1b, randomized, multi-dose, placebo-controlled, dose-escalation, multi-center study of AMP-110 in adult subjects with rheumatoid arthritis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: July 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Must be able to provide written informed consent

• Body mass index 18.5 to 35.0 kg/m2

• Diagnosis of Rheumatoid Arthritis according to 1987 revised American College of Rheumatology (ACR) criteria

• Global Functional Class I, II, or III according to ACR 1991 revised criteria

• Must have at least 4 tender joints and 4 swollen joints (28-joint assesssment)

• Use of >/= 1 non-steroidal anti-inflammatory drugs is allowed, subject must be on a stable dose for >/= 2 weeks prior to randomization

• Use of >/= 1 Disease Modifying Anti-rheumatic Drugs (DMARD) for >/= 3 months and a stable dose for >/= 6 weeks prior to randomization

• Stable use of low dose oral corticosteroids (</= 10 mg prednisone per day or equivalent) is allowed; subjects must be on a stable dose for >/= 4 weeks prior to randomization

Exclusion Criteria:

• Prior to Day 0, use of:

1. Rituximab within 6 months

2. Abatacept within 3 months

3. Infliximab, Adalimumab, Certolizumab, Tocilizumab, Cyclosporine, Azathioprine or Mycophenolate mofetil within 2 months

4. Etanercept, Anakinra, immunoglobulin or blood products within 28 days

5. Prior immunotherapy, including high dose oral corticosteroids or systemic corticosteroids such as prednisone, biologics, Janus kinase (JAK) inhibitors, such as tofacitinib or investigational therapy must have completed at least 5 half-lives or 30 days, whichever is longer

6. Prior exposure to T cell depleting agents such as Campath (alemtuzumab)

• Evidence of any active or recent infection

• History of systemic autoimmune disease other than Rheumatoid Arthritis; secondary Sjogren's syndrome, rheumatoid vasculitis and orther extra-articular manifestations of RA allowed

• History of allergic reactions

• History of anaphylaxis or allergic diathesis

• Clinically significant cardiac disease, including: unstable angina; myocardial infarction within 6 months; congestive heart failure; arrhythmia requiring active therapy, with the exception of clinically insignificant extrasystoles, or minor conduction abnormalities; and history of clinically significant abnormality on electrocardiogram

• Evidence of active or latent tuberculosis

• Vaccination with live attenuated viruses within the 2 weeks prior to Day 0

• Pregnant or breastfeeding women

Study Design

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• AMP-110
2, 5, or 10 mg/kg

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Pinnacle Research Group, LLC	Anniston	Alabama
United States	Metroplex Clinical Research Center	Dallas	Texas
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Arthritis Treatment Center	Frederick	Maryland
United States	Physician Research Collaboration, LLC	Lincoln	Nebraska
United States	Omega Research Consultants, LLC.	Orlando	Florida
United States	Arthritis Center, Inc.	Palm Harbor	Florida

Sponsors (2)

Lead Sponsor	Collaborator
MedImmune LLC	Daiichi Sankyo Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical responses via RA disease scoring systems	Explore the pharmacodynamics (PD) of repeat doses of AMP-110 versus placebo in subjects with RA	From start of study drug administration through Day 112	Yes
Primary	Acceptable number of adverse events per subject as a measure of safety and tolerability of repeat doses of AMP-110 versus placebo	Determined by the number of AEs, SAEs, and results in laboratory evaluations, vital signs, electrocardiograms and physical examinations	From start of study drug administration through Day 112	Yes
Primary	Repeat dose pharmacokinetic parameters of AMP-110 in serum	Parameters will include maximum observed concentration (Cmax), area under the concentration-time curve (AUC), total body clearance and terminal half-life	From start of study drug administration through Day 112	Yes
Secondary	Optimal dose for repeat dosing of AMP-110	Optimal dose will be determined through the occurrence of AEs, SAEs, ACR-20 and DAS-28 results, and individual AMP-110 concentrations in serum including peak and trough levels	From start of study drug administration through Day 112	Yes