Arthritis, RheumatoidPhase 1SPARTANCT01749787
Safety Study of PRTX-100 With Methotrexate or Leflunomide to Treat Active Rheumatoid Arthritis
A Phase 1 study testing PRTX-100 at 1.5 mcg/kg, PRTX-100 at 3.0 mcg/kg and PRTX-100 at 6.0 mcg/kg in people with Arthritis, Rheumatoid, run by Protalex, Inc. at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- PRTX-100 at 1.5 mcg/kg, PRTX-100 at 3.0 mcg/kg and PRTX-100 at 6.0 mcg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 8 sitesUnited States
- Study dates
- Nov 2012to Aug 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active RA with disease duration of not less than 6 months
- Concomitant stable methotrexate or leflunomide therapy
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Protalex Investigational Site
Albuquerque, New Mexico, 87102
Protalex Investigational Site
Allen, Texas, 75013
Protalex Investigational Site
Anderson, Indiana, 46011
Protalex Investigational Site
Coeur d'Alene, Idaho, 83814
Protalex Investigational Site
Duncansville, Pennsylvania, 16635
Protalex Investigative Site
Los Angeles, California, 90036
Protalex Investigational Site
Salisbury, North Carolina, 28144
Protalex Investigational Site
Sarasota, Florida, 34239
About this study
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
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.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- 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
- Keywords
- arthritis, rheumatoid, methotrexate, leflunomide
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRTX-100 at 1.5 mcg/kgDrug
Also called Staphylococcal Protein A, SpA
PRTX-100 at 3.0 mcg/kgDrug
Also called Staphylococcal Protein A, SpA
PRTX-100 at 6.0 mcg/kgDrug
Also called Staphylococcal Protein A, SpA
PRTX-100 at 12.0 mcg/kgDrug
Also called Staphylococcal Protein A, SpA
PRTX-100 at 240 mcgDrug
Also called Staphylococcal Protein A, SpA
PlaceboDrug
Placebo administered via infusion once per week for 5 weeks
PRTX-100 at 420 mcgDrug
Also called Staphylococcal Protein A, SpA
| Study group | Role | What they receive |
|---|---|---|
| 1.5 mcg/kg | Experimental | PRTX-100 at 1.5 mcg/kg administered via infusion once per week for 5 weeks Receives: Drug: PRTX-100 at 1.5 mcg/kg |
| 3.0 mcg/kg | Experimental | PRTX-100 at 3.0 mcg/kg administered via infusion once per week for 5 weeks Receives: Drug: PRTX-100 at 3.0 mcg/kg |
| 6.0 mcg/kg | Experimental | PRTX-100 at 6.0 mcg/kg administered via infusion once per week for 5 weeks Receives: Drug: PRTX-100 at 6.0 mcg/kg |
| 12.0 mcg/kg | Experimental | PRTX-100 at 12.0 mcg/kg administered via infusion once per week for 5 weeks Receives: Drug: PRTX-100 at 12.0 mcg/kg |
| 240 mcg | 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. Receives: Drug: PRTX-100 at 240 mcg |
| Placebo | Placebo comparator | Placebo administered via infusion once per week for 5 weeks Receives: Drug: Placebo |
| 420 mcg | 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. Receives: Drug: PRTX-100 at 420 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Number, severity and attribution of relatedness of Adverse Events
Measured: Screening up to 53 Weeks
Vital Signs and Physical Examinations
Change from baseline in blood pressure, heart rate, body temperature, and physical examination parameters
Measured: Screening up to 25 Weeks
ECG
Change from baseline in heart rate, PR interval, QT/QTc interval and QRS duration
Measured: Screening, first dose, 5th dose, 9 weeks, and 25 weeks
Clinical Laboratory Testing
Change from baseline in blood chemistry, hematology, and urinalysis values
Measured: Screening up to 25 weeks
Secondary outcomes (3)
Disease activity
Number and percentage of patients attaining an ACR20, ACR50 and ACR70 response at Week 13. Change from baseline in CDAI, RAPID 3, and DAS28-CRP scores.
Measured: Screening up to 53 weeks
Immunogenicity
Proportion of patients sero-positive and/or with titers > 512 at Week 4 and Week 9, the correlation between anti-product antibody and product clearance, and association between anti-product antibodies and adverse events.
Measured: Prior to first dose, and at 4 weeks, 9 weeks, and 25 weeks
Pharmacokinetics
Plasma Cmax, AUC0-n, clearance and Vd.
Measured: Prior to first dose up to 72 hours after last dose of PRTX-100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Protalex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William E Gannon, M.D., Study director, Protalex, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749787
- Sponsor's protocol ID
- PRTX-100-104
- Acronym
- SPARTA
- Status last verified
- Dec 2014
- First submitted
- 6 Dec 2012
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01749787
- Acronym / sponsor ID
- SPARTA / PRTX-100-104
- Conditions
- Arthritis, Rheumatoid
- Keywords
- arthritis, rheumatoid, methotrexate, leflunomide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Protalex, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 1.5 mcg/kg | Experimental | Drug: PRTX-100 at 1.5 mcg/kgPRTX-100 at 1.5 mcg/kg administered via infusion once per week for 5 weeks |
| 3.0 mcg/kg | Experimental | Drug: PRTX-100 at 3.0 mcg/kgPRTX-100 at 3.0 mcg/kg administered via infusion once per week for 5 weeks |
| 6.0 mcg/kg | Experimental | Drug: PRTX-100 at 6.0 mcg/kgPRTX-100 at 6.0 mcg/kg administered via infusion once per week for 5 weeks |
| 12.0 mcg/kg | Experimental | Drug: PRTX-100 at 12.0 mcg/kgPRTX-100 at 12.0 mcg/kg administered via infusion once per week for 5 weeks |
| 240 mcg | Experimental | Drug: PRTX-100 at 240 mcgPRTX-100 at 240 mcg/dose administered via infusion once per week for 5 weeks then once every four weeks for 16 weeks thereafter. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered via infusion once per week for 5 weeks |
| 420 mcg | Experimental | Drug: PRTX-100 at 420 mcgPRTX-100 at 420 mcg/dose administered via infusion once per week for 5 weeks then once every four weeks for 16 weeks thereafter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Active RA with disease duration of not less than 6 months
- Concomitant stable methotrexate or leflunomide therapy
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRTX-100 at 1.5 mcg/kgAlso: Staphylococcal Protein A, SpA | Drug | 1.5 mcg/kg |
| PRTX-100 at 3.0 mcg/kgAlso: Staphylococcal Protein A, SpA | Drug | 3.0 mcg/kg |
| PRTX-100 at 6.0 mcg/kgAlso: Staphylococcal Protein A, SpA | Drug | 6.0 mcg/kg |
| PRTX-100 at 12.0 mcg/kgAlso: Staphylococcal Protein A, SpA | Drug | 12.0 mcg/kg |
| PRTX-100 at 240 mcgAlso: Staphylococcal Protein A, SpA | Drug | 240 mcg |
| PlaceboPlacebo administered via infusion once per week for 5 weeks | Drug | Placebo |
| PRTX-100 at 420 mcgAlso: Staphylococcal Protein A, SpA | Drug | 420 mcg |
Primary outcome
Adverse Events
Time frame: Screening up to 53 Weeks
Number, severity and attribution of relatedness of Adverse Events
Vital Signs and Physical Examinations
Time frame: Screening up to 25 Weeks
Change from baseline in blood pressure, heart rate, body temperature, and physical examination parameters
ECG
Time frame: Screening, first dose, 5th dose, 9 weeks, and 25 weeks
Change from baseline in heart rate, PR interval, QT/QTc interval and QRS duration
Clinical Laboratory Testing
Time frame: Screening up to 25 weeks
Change from baseline in blood chemistry, hematology, and urinalysis values
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William E Gannon, M.D. study director
Protalex, Inc.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PRTX-100 at 1.5 mcg/kg, PRTX-100 at 3.0 mcg/kg and PRTX-100 at 6.0 mcg/kg in people with Arthritis, Rheumatoid, run by Protalex, Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: Screening up to 53 Weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2014.