Rituxan With or Without Methotrexate in Psoriatic Arthritis

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Psoriatic Arthritis	Drug: Rituximab	Phase 1

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	6 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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 Start Date :	December 2006
Actual Primary Completion Date :	January 2010
Actual Study Completion Date :	March 2010

Arms and Interventions

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Intervention Details:

• Drug: Rituximab
  1000mg (1gm) given as an IV infusion every two weeks for 2 doses (days 1 and 15). The first infusion of rituximab should be administered IV at an initial rate of 50 mg/hr. If a hypersensitivity or infusion related reaction does not occur, escalate the infusion rate by 50 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr.
  Other Name: Rituxan

Outcome Measures

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Primary Outcome Measures :

1. Safety of Rituximab in PSA and psoriasis by determining incidence of treatment emergent AE's including infections, infusion reactions and disease progression. [ Time Frame: followed out for one year from last dose ]

Secondary Outcome Measures :

1. 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. [ Time Frame: Week 24 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United States, California
University of California, San Diego
La Jolla, California, United States, 92037-0943
Stanford University
Stanford, California, United States, 94305-5350
United States, New York
University of Rochester
Rochester, New York, United States, 14642
United States, Washington
Swedish Rheumatology Research
Seattle, Washington, United States, 98104

Sponsors and Collaborators

Swedish Medical Center

Genentech, Inc.

Investigators

Principal Investigator:	Philip J Mease, MD	Seattle Rheumatology Associates/ Swedish Research Center

More Information

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Responsible Party:	Swedish Medical Center
ClinicalTrials.gov Identifier:	NCT00509678 History of Changes
Other Study ID Numbers:	U3081n
First Posted:	July 31, 2007
Last Update Posted:	January 18, 2012
Last Verified:	January 2012

Keywords provided by Swedish Medical Center:

Rituximab; Rituxan; Psoriatic Arthritis; Arthritis

Additional relevant MeSH terms:

Arthritis; Arthritis, Psoriatic; Joint Diseases; Musculoskeletal Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Rituximab; Methotrexate; Antineoplastic Agents	Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Reproductive Control Agents; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Dermatologic Agents; Enzyme Inhibitors; Folic Acid Antagonists; Immunosuppressive Agents; Nucleic Acid Synthesis Inhibitors