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Completed

NCT Number: NCT02047604

(C2013-0302) Safety and Efficacy of Escalating Doses of SAN-300 in Patients With Rheumatoid Arthritis

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).

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Santarus Clinical Investigational Site 1012, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

SAN-300 0.5 mg/kg QW

Drug

SAN-300 1.0 mg/kg QW

Drug

SAN-300 2.0 mg/kg QOW

Drug

SAN-300 4.0 mg/kg QOW

Drug

SAN-300 4.0 mg/kg QW

Drug

Placebo

Drug

Primary outcomes

  1. Number of Participants With Adverse Events

    Time frame: 10 weeks

    Adverse events data are collected during a 10-week period, which includes 6 weeks of treatment and 4 weeks of follow-up.

Secondary outcomes

  1. Change From Baseline in Disease Activity Score With 28-joint Count Using C-reactive Protein (DAS28-CRP)

    Time frame: Baseline, End of Treatment Visit (Week 7)

    DAS28-CRP= 0.56 x sqrt(TJC28) x sqrt(SJC28) + 0.36 x ln(CRP+1) +0.014 x VAS +0.96 Where TJC28: The number of tender joints (0-28). SJC28: The number of swollen joints (0-28). CRP: The C-Reactive Protein level (in mg/l). VAS General Health Assessment (from 0=best to 100=worst). ln=natural log. sqrt = square root. Higher scores indicate worse outcome.

  2. Number of Participants With American College of Rheumatology 20 (ACR20) Response.

    Time frame: End of Treatment Visit (Week 7)

    A participant is considered to have an ACR20 response if there is an improvement of 20% in all of the following:

    • Swollen joint count (66 joints)
    • Tender joint count (68 joints) and
    • At least three of the following five assessments:
    • Patient's assessment of pain
    • Patient's global assessment of disease activity
    • Physician's global assessment of disease activity
    • Patient's assessment of physical function, as measured by the HAQ-DI
    • CRP

Other outcomes

  1. Change From Baseline in the Health Assessment Questionnaire-Disease Index (HAQ-DI)

    Time frame: Baseline, End of Treatment Visit (Week 7)

    HAQ assesses the degree of difficulty a participant has had in accomplishing tasks in eight functional areas, over the previous week.

    • dressing and grooming,
    • rising,
    • eating,
    • walking,
    • hygiene,
    • reach,
    • grip,
    • common daily activities. For each of these categories, participants report amount of difficulty they have in performing two or three specific activities. There are four possible responses for the HAQ questions: without ANY difficulty

    (0), with SOME difficulty (1), with MUCH difficulty (2) and UNABLE to do (3). Scores for each of the eight categories are calculated. HAQ is calculated by adjusting the score for each of these categories, if necessary, based upon the patient's use of an aid, device, or assistance for that category, totaling the sum of the category scores and dividing by the number of categories answered. HAQ can range from 0 to 3. Higher scores (greater level of difficulty) indicate worse outcome.

  2. Bone Erosion Detected Using Magnetic Resonance Imaging (MRI) Findings of the Hand and Wrist - Change From Baseline

    Time frame: Baseline, End of Treatment Visit (Week 7)

    Bone Erosion detected by MRI of hand/wrist was scored using the Outcome Measures in Rheumatology Clinical Trials (OMERACT) RA MRI scoring (RAMRIS) system. Bone erosion was scored 0-10, according to the proportion (in increments of 10%) of erosion of articular bone: 0: 0%, 1: 1%-10%, 2: 11%-20%, ……..10: 91%-100%. Higher scores (more erosion) indicate worse outcome.

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Registry information

Official study 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).

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jan 28, 2014
Registry last updated
Jun 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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