Mark Genovese
Rituximab with or without Methotrexate in subjects with psoriatic arthritis and psoriasis
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
This study will evaluate the safety and efficacy of using rituximab in patients with psoriatic arthirtis or psoriasis providing information on a potential alternative treatment for those patients who do not have an adequate response to either anti-TNF or MTX therapy. In addition, insight into the biologic mechanism of action of the diseases will be gained.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Rituximab
Phase:
Phase 1/Phase 2Eligibility
Ages Eligible for Study:
18 years to 80 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
2. Age 18-80
3. Disease duration > 6 months
4. Receiving treatment on an outpatient basis.
5. The patient will have at least one evaluable skin plaque, 2 cm in diameter, that can be followed with a target lesion score (not only in the scalp or groin).
6. Presence of PsA falling within one of the five Moll & Wright categories: asymmetric oligoarticular, asymmetric or symmetric polyarticular without rheumatoid nodules, DIP predominant, spondylitic PsA, or arthritis mutilans.
7. Subjects will have greater than or equal to 3 tender and 3 swollen joints at screening.
8. Using corticosteroids ? 10 mg/day prednisone or equivalent) if the dose has been stable for at least 4 weeks prior to screening; nonsteroidal anti-inflammatory drugs (NSAIDs) are permitted if the dose has been stable for at least 2 weeks prior to screening.
9. If the patient is taking methotrexate (MTX), the patient must have received methotrexate 7.5-25 mg/wk (p.o. or parenteral) for at least 12 weeks, with at least the last 4 weeks prior to screening at a stable dose. If the patient is not taking MTX, they must have been off the drug for at least 8 weeks.
10. Whether or not the patient is taking methotrexate, all DMARDs (other than MTX) should be withdrawn at least 4 weeks prior to randomization (4 weeks for etanercept and 12 weeks for efluzimab, infliximab, adalimumab and leflunomide).
11. Folic acid is required at least 1mg per day or 7mg per week.
12. If the patient is of reproductive potential (males and females, even if a tubal ligation has been done) using a reliable means of contraception (e.g., contraceptive pill, intrauterine device [IUD], and physical barrier).
13. If female and of childbearing potential, have a negative serum pregnancy test at screen (results returned before baseline) and a negative urine pregnancy test just prior to each infusion.
Key Exclusion Criteria:
1. History of malignancy other than resolved squamous or basal cell or cervical carcinoma
2. Presence of a significant medical illness that, in the opinion of the investigator, would potentially compromise the subject?s ability to participate in the trial
3. Presence of another rheumatic or skin disease that, in the opinion of the investigator, could confound the ability to discern response,
4. History or presence of HIV, hepatitis B surface antigen or hepatitis C antibody
5. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
6. History of recurrent significant infection or history of recurrent bacterial infections
7. Known active bacterial, viral, fungal, mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with i.v. antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening.
8. History of psychiatric disorder that, in the judgment of the investigator, would make the patient inappropriate for entry into this trial or would lead to poor compliance.
9. Significant cardiac or pulmonary disease (including obstructive pulmonary disease)
10. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that, in the opinion of the investigator, contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
11. Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal disorders.
12. History of, or current, inflammatory joint disease other than PSA (e.g., gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease) or other systemic rheumatic disorder (e.g., systemic lupus erythematosus (SLE), inflammatory bowel disease, scleroderma, inflammatory myopathy, overlap syndrome) that will interfere with clinical evaluation in the judgment of the investigator.
Additional Study Details
Official Title:
Phase IB, Investigator-Initiated, Open-Label, Multi-Center Trial of Rituximab With and Without Methotrexate in Subjects with Psoriatic Arthritis and PsoriasisAnticipated start date:
12/13/2006Lead Sponsor:
Swedish Medical CenterCollaborator(s):
- Genentech; Univ. San Diego, Univ. of Rochester;
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- safety
Secondary Outcomes:
- efficacy
Total Number to be Enrolled:
20Total Number to be Enrolled at Stanford:
6More Information
Secondary ID(s):
- IRB #5757
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
This study is being conducted at multiple locations, including non-Stanford locations.
This listing was last updated:
11/26/2007PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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