Rituxan With or Without Methotrexate in Psoriatic Arthritis
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ClinicalTrials.gov Identifier: NCT00509678 |
Recruitment Status
:
Completed
First Posted
: July 31, 2007
Last Update Posted
: January 18, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Psoriatic Arthritis | Drug: Rituximab | Phase 1 |
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 |

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Drug: Rituximab
- 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 ]
- 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 ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00509678
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 |
Principal Investigator: | Philip J Mease, MD | Seattle Rheumatology Associates/ Swedish Research Center |
Responsible Party: | Swedish Medical Center |
ClinicalTrials.gov Identifier: | NCT00509678 History of Changes |
Other Study ID Numbers: |
U3081n |
First Posted: | July 31, 2007 Key Record Dates |
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 |