Overview

This trial is active, not recruiting.

Condition arthritis, rheumatoid
Treatments prtx-100 at 1.5 mcg/kg, prtx-100 at 3.0 mcg/kg, prtx-100 at 6.0 mcg/kg, prtx-100 at 12.0 mcg/kg, prtx-100 at 240 mcg, placebo, prtx-100 at 420 mcg
Phase phase 1
Sponsor Protalex, Inc.
Start date November 2012
End date August 2014
Trial size 64 participants
Trial identifier NCT01749787, PRTX-100-104

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
PRTX-100 at 1.5 mcg/kg administered via infusion once per week for 5 weeks
prtx-100 at 1.5 mcg/kg Staphylococcal Protein A
(Experimental)
PRTX-100 at 3.0 mcg/kg administered via infusion once per week for 5 weeks
prtx-100 at 3.0 mcg/kg Staphylococcal Protein A
(Experimental)
PRTX-100 at 6.0 mcg/kg administered via infusion once per week for 5 weeks
prtx-100 at 6.0 mcg/kg Staphylococcal Protein A
(Experimental)
PRTX-100 at 12.0 mcg/kg administered via infusion once per week for 5 weeks
prtx-100 at 12.0 mcg/kg Staphylococcal Protein A
(Experimental)
PRTX-100 at 240 mcg/dose administered via infusion once per week for 5 weeks then once every four weeks for 16 weeks thereafter.
prtx-100 at 240 mcg Staphylococcal Protein A
(Placebo Comparator)
Placebo administered via infusion once per week for 5 weeks
placebo
Placebo administered via infusion once per week for 5 weeks
(Experimental)
PRTX-100 at 420 mcg/dose administered via infusion once per week for 5 weeks then once every four weeks for 16 weeks thereafter.
prtx-100 at 420 mcg Staphylococcal Protein A

Primary Outcomes

Measure
Adverse Events
time frame: Screening up to 53 Weeks
Vital Signs and Physical Examinations
time frame: Screening up to 25 Weeks
ECG
time frame: Screening, first dose, 5th dose, 9 weeks, and 25 weeks
Clinical Laboratory Testing
time frame: Screening up to 25 weeks

Secondary Outcomes

Measure
Disease activity
time frame: Screening up to 53 weeks
Immunogenicity
time frame: Prior to first dose, and at 4 weeks, 9 weeks, and 25 weeks
Pharmacokinetics
time frame: Prior to first dose up to 72 hours after last dose of PRTX-100

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Protalex, Inc..