Clinical trial NCT02047604: (C2013-0302) Safety and Efficacy of Escalating Doses of SAN-300 in Patients With Rheumatoid Arthritis
Official title: A Randomized, Double-blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Escalating Doses of SAN-300 in Patients With Active Rheumatoid Arthritis With Inadequate Response to Disease-Modifying Anti-rheumatic Drug(s).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Phase 2a multiple ascending dose, Anti-Very Late Antigen-1
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2014-01-28
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Escalating Doses of SAN-300 in Patients with Active Rheumatoid Arthritis with Inadequate Response to Disease-Modifying Anti-rheumatic Drug(s).


Eligibility criteria: Inclusion Criteria:

1. Diagnosed with RA for ≥ 6 months according to American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria 2010
2. 18 to 75 years of age, inclusive, at the time of informed consent
3. Swollen joint count of ≥ 6 (66-joint count) and tender joint count of ≥ 6 (68-joint count) at Screening and randomization
4. Inadequate response to therapy or discontinuation of therapy because of unacceptable toxicity from at least one prior traditional or biologic disease-modifying anti-rheumatic drug (DMARD)
5. Stable dose of methotrexate (≥ 15 mg/week and ≤ 25 mg/week) for ≥ 6 weeks before randomization

Exclusion Criteria:

1. Functional Class IV as defined by ACR classification of functional status in RA
2. History of significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis, or Felty's syndrome)
3. History of malignancy or carcinoma in situ within the 5 years before Screening or any history of melanoma. Patients with history of excised or adequately treated non-melanoma skin cancer are eligible
4. Evidence of clinically significant uncontrolled concurrent diseases such as cardiovascular, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major diseases
5. History of recurrent clinically significant infections
6. Current active infection or serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within 3 months before randomization
7. History of severe allergic or anaphylactic reactions to other biologic agents
8. History of allergies to murine protein
9. Surgery within 3 months before randomization (other than minor cosmetic surgery or minor dental procedures) or plans for a surgical procedure during the Treatment Period or Follow-up Period
10. History of tuberculosis or latent infection currently undergoing treatment
11. History of malaria
12. Treatment regimen with prednisone that is either over 10 mg/day (or equivalent dose of another corticosteroid) or is not taken at a stable dose of ≤ 10 mg/day for at least 4 weeks before randomization
13. Intra-articular corticosteroid injection(s) within 4 weeks before randomization
14. Any live immunization/vaccination, including against Herpes zoster, within 4 weeks before randomization. Live vaccinations must also be avoided throughout the study
15. Abnormal laboratory value at Screening or Day -1 considered clinically significant
16. Positive for hepatitis C virus (HCV) antibody or hepatitis B surface antigen (HBsAg)
17. Positive for human immunodeficiency virus (HIV) antibody
18. History of tuberculosis or positive QuantiFERON®-TB Gold test (QFT)

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 10 weeks
Secondary outcomes:
measure: Change From Baseline in Disease Activity Score With 28-joint Count Using C-reactive Protein (DAS28-CRP)
timeFrame: Baseline, End of Treatment Visit (Week 7)
measure: Number of Participants With American College of Rheumatology 20 (ACR20) Response.
timeFrame: End of Treatment Visit (Week 7)
Other outcomes:
measure: Change From Baseline in the Health Assessment Questionnaire-Disease Index (HAQ-DI)
timeFrame: Baseline, End of Treatment Visit (Week 7)
measure: Bone Erosion Detected Using Magnetic Resonance Imaging (MRI) Findings of the Hand and Wrist - Change From Baseline
timeFrame: Baseline, End of Treatment Visit (Week 7)
Locations:
city: Phoenix
country: United States
facility: Santarus Clinical Investigational Site 1012
state: Arizona
city: El Cajon
country: United States
facility: Santarus Clinical Investigational Site 1004
state: California
city: Los Angeles
country: United States
facility: Santarus Clinical Investigational Site 1008
state: California
city: San Leandro
country: United States
facility: Santarus Clinical Investigational Site 1011
state: California
city: Brandon
country: United States
facility: Santarus Clinical Investigational Site 1013
state: Florida
city: Palm Harbor
country: United States
facility: Santarus Clinical Investigational Site 1003
state: Florida
city: Florissant
country: United States
facility: Santarus Clinical Investigational Site 1017
state: Missouri
city: Brooklyn
country: United States
facility: Santarus Clinical Investigational Site 1009
state: New York
city: Chapel Hill
country: United States
facility: Santarus Clinical Investigational Site 1019
state: North Carolina
city: Charlotte
country: United States
facility: Santarus Clinical Investigational Site 1014
state: North Carolina
city: Salisbury
country: United States
facility: Santarus Clinical Investigational Site 1006
state: North Carolina
city: Middleburg Heights
country: United States
facility: Santarus Clinical Investigational Site 1001
state: Ohio
Study officials:
References: