Phase 2
Completed N=41
(C2013-0302) Safety and Efficacy of Escalating Doses of SAN-300 in Patients With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT02047604 ↗Enrolled (actual)
41
Serious AEs
4.9%
Results posted
Jun 2021
Primary outcomePrimary: Number of Participants With Adverse Events — 5; 4; 2; 6 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
5; 4; 2; 6; 4; 7 | — |
| SECONDARY Change From Baseline in Disease Activity Score With 28-joint Count Using C-reactive Protein (DAS28-CRP) |
-4.433; -3.663; -2.002; -3.818; -2.928; -3.028 | — |
| SECONDARY Number of Participants With American College of Rheumatology 20 (ACR20) Response. |
3; 3; 1; 2; 1; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosed with RA for ≥ 6 months according to American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria 2010
- 18 to 75 years of age, inclusive, at the time of informed consent
- Swollen joint count of ≥ 6 (66-joint count) and tender joint count of ≥ 6 (68-joint count) at Screening and randomization
- 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)
- Stable dose of methotrexate (≥ 15 mg/week and ≤ 25 mg/week) for ≥ 6 weeks before randomization
Exclusion Criteria
- Functional Class IV as defined by ACR classification of functional status in RA
- History of significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis, or Felty's syndrome)
- 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
- 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
- History of recurrent clinically significant infections
- Current active infection or serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within 3 months before randomization
- History of severe allergic or anaphylactic reactions to other biologic agents
- History of allergies to murine protein
- 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
- History of tuberculosis or latent infection currently undergoing treatment
- History of malaria
- 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
- Intra-articular corticosteroid injection(s) within 4 weeks before randomization
- Any live immunization/vaccination, including against Herpes zoster, within 4 weeks before randomization. Live vaccinations must also be avoided throughout the study
- Abnormal laboratory value at Screening or Day -1 considered clinically significant
- Positive for hepatitis C virus (HCV) antibody or hepatitis B surface antigen (HBsAg)
- Positive for human immunodeficiency virus (HIV) antibody
- History of tuberculosis or positive QuantiFERON®-TB Gold test (QFT)
Data sourced from ClinicalTrials.gov (NCT02047604). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.