Clinical trial NCT00509678: Rituxan With or Without Methotrexate in Psoriatic Arthritis
Official title: Phase IB, Investigator-Initiated, Open-Label, Multi-Center Trial of Rituximab With or Without Methotrexate In Subjects With Psoriatic Arthritis and Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriatic Arthritis
Keywords: Rituximab
Rituxan
Psoriatic Arthritis
Arthritis
Lead sponsor: Swedish Medical Center
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2007-07-31
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to help determine the effectiveness of rituxan (with or without methotrexate) in the treatment of psoriatic arthritis.

Detailed description: The purpose of this study is to evaluate safety and efficacy of rituximab, with and without methotrexate, in joints, enthesium and skin in psoriatic arthritis patients with inadequate response to methotrexate who have either not tried anti-TNF therapy or have had inadequate or failed response to anti-TNF therapy. To explore biologic mechanism of action via histological and immunohistochemical evaluation of pre and post treatment biopsies of psoriatic plaques.

Eligibility criteria: Inclusion Criteria:

* Active disease of at least 6 months duration.
* Receiving treatment on an outpatient basis.
* The patient will have at least one evaluable skin plaque, 2 cm in diameter, that can be followed with a target lesion score (scalp and groin lesions cannot be used).
* Presence of PsA per the CASPAR categories: Psoriasis, Nail Changes, Negative RF test, Dactylitis or radiological evidence of juxta-articular new bone formation.
* Subjects will have greater than or equal to 3 tender (out of 68 joints) and 3 swollen (out of 66) joints at screening and baseline.

Exclusion Criteria:

* History of malignancy other than resolved squamous or basal cell or cervical carcinoma
* 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
* Presence of another rheumatic or skin disease that, in the opinion of the investigator, could confound the ability to discern response
* History or presence of HIV
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
* History of recurrent significant infection or history of recurrent bacterial infections
* 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.
* 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.
* Concurrent treatment with any DMARD (except for MTX), any anti-TNF alpha therapy or other biologic therapy. Topical medications to treat psoriasis are limited to class VI and VII low potency steroids to the palms, soles of the feet, axilla and groin only.
* Concurrent treatment with any DMARD (except for MTX), any anti-TNF alpha therapy or other biologic therapy. Topical medications to treat psoriasis are limited to class VI and VII low potency steroids to the palms, soles of the feet, axilla and groin only.
* Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer).
* Previous treatment with any cell-depleting therapies, including investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19).
* Previous treatment within 6 months with i.v. gamma-globulin, Orencia, toclizumab, natalizumab or Prosorba Column.
* Intra-articular or parental corticosteroid injections within 4 weeks prior to screening.
* Previous treatment with rituximab (MabThera/Rituxan)
* Immunization with a vaccine within 4 weeks prior to randomization (e.g.; MMR, Varivax, Smallpox).
* One intra-articular steroid joint injection is allowed, affected joint is excluded from assessment thereafter.
* Subjects should not take analgesics within 12 hours prior to joint assessments

Primary outcomes:
measure: Safety of Rituximab in PSA and psoriasis by determining incidence of treatment emergent AE's including infections, infusion reactions and disease progression.
timeFrame: followed out for one year from last dose
Secondary outcomes:
measure: The exploration of efficacy of rituximab in PsA will be determined by using the week 24 ACR 20 measurement as modified for PsA using 68/66 tender/swollen joint count.
timeFrame: Week 24
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Seattle
country: United States
facility: Swedish Rheumatology Research
state: Washington
Study officials:
affiliation: Seattle Rheumatology Associates/ Swedish Research Center
name: Philip J Mease, MD
role: PRINCIPAL_INVESTIGATOR
References: