Clinical trial NCT01749787: Safety Study of PRTX-100 With Methotrexate or Leflunomide to Treat Active Rheumatoid Arthritis
Official title: A Phase Ib Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Dose Escalation, Safety and Tolerability Study of PRTX-100 in Combination With Methotrexate or Leflunomide in Patients With Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Arthritis, Rheumatoid
Keywords: arthritis
rheumatoid
methotrexate
leflunomide
Lead sponsor: Protalex, Inc.
Sponsor class: INDUSTRY
First posted: 2012-12-17
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and tolerability of PRTX-100 when various doses are given 5 times at weekly intervals to patients with active rheumatoid arthritis that are taking methotrexate or leflunomide. The drug is administered in a physician's office via an intravenous infusion. PRTX-100 may be effective in rheumatoid arthritis by suppressing the immune responses.

PRTX-100 is a highly-purified bacterial protein called Staphylococcal Protein A. In this study, cohorts of patients with active RA will receive sequentially higher doses of PRTX-100. There will be an inactive placebo cohort for comparison. Patients who do not attain low RA disease activity, by a commonly used measure, will leave the study at 3 months after their first dose of study drug.


Eligibility criteria: Inclusion Criteria:

* Active RA with disease duration of not less than 6 months
* Concomitant stable methotrexate or leflunomide therapy

Exclusion Criteria:

* Diagnosis of any other inflammatory arthritis
* ACR Functional Classification of IV
* Significant systemic involvement secondary to RA (except for secondary Sjogren's syndrome)
* History of clincally significant hypogammaglobulinemia, common variable immunodeficiency, or humeral immunodeficientncy
* History of active tuberculosis, pro-thrombotic disorder, venous thrombosis requiring anti-coagulation, substance abuse, or serious psychiatric condition
* History of allergy or hypersensitivity to aspirin or non-steroidal cyclooxygenase inhibitors, Staphylococcal protein A
* History or presence of malignancy (except for surgically treated basal or squamous cell carcinoma of the skin at least 3 months prior to the start of study medication)
* Uncontrolled diabetes or Type 1 diabetes
* Unstable ischemic heart disease
* Serious active or recurrent infection, hepatic cirrhosis, or other medically unstable condition
* Systemic autoimmune diseases other than RA (such as systemic lupus erythematosus, scleroderma, inflammatory bowel disease, inflammatory myopathy)
* Positive for HIV, hepatitis B surface antigen, or hepatitis C antibody
* Pregnant or nursing females
* Inadequate hepatic, renal, or hematologic function
* Receipt of live vaccine within 5 weeks of start of study medication
* Concomitant administration of other biologic or non-biologic DMARDS, corticosteroids, or anti-CD20 antibodies

Primary outcomes:
measure: Adverse Events
timeFrame: Screening up to 53 Weeks
measure: Vital Signs and Physical Examinations
timeFrame: Screening up to 25 Weeks
measure: ECG
timeFrame: Screening, first dose, 5th dose, 9 weeks, and 25 weeks
measure: Clinical Laboratory Testing
timeFrame: Screening up to 25 weeks
Secondary outcomes:
measure: Disease activity
timeFrame: Screening up to 53 weeks
measure: Immunogenicity
timeFrame: Prior to first dose, and at 4 weeks, 9 weeks, and 25 weeks
measure: Pharmacokinetics
timeFrame: Prior to first dose up to 72 hours after last dose of PRTX-100
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Protalex Investigative Site
state: California
city: Sarasota
country: United States
facility: Protalex Investigational Site
state: Florida
city: Coeur d'Alene
country: United States
facility: Protalex Investigational Site
state: Idaho
city: Anderson
country: United States
facility: Protalex Investigational Site
state: Indiana
city: Albuquerque
country: United States
facility: Protalex Investigational Site
state: New Mexico
city: Salisbury
country: United States
facility: Protalex Investigational Site
state: North Carolina
city: Duncansville
country: United States
facility: Protalex Investigational Site
state: Pennsylvania
city: Allen
country: United States
facility: Protalex Investigational Site
state: Texas
Study officials:
affiliation: Protalex, Inc.
name: William E Gannon, M.D.
role: STUDY_DIRECTOR
References: