Rituxan With or Without Methotrexate in Psoriatic Arthritis

Tracking Information
First Submitted Date ICMJE	July 27, 2007
First Posted Date ICMJE	July 31, 2007
Last Update Posted Date	January 18, 2012
Study Start Date ICMJE	December 2006
Actual Primary Completion Date	January 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: July 30, 2007)	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 ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00509678 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: July 30, 2007)	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 ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Rituxan With or Without Methotrexate in Psoriatic Arthritis
Official Title ICMJE	Phase IB, Investigator-Initiated, Open-Label, Multi-Center Trial of Rituximab With or Without Methotrexate In Subjects With Psoriatic Arthritis and Psoriasis
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.
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Psoriatic Arthritis
Intervention ICMJE	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
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: January 16, 2012)	6
Original Estimated Enrollment ICMJE; (submitted: July 30, 2007)	20
Actual Study Completion Date	March 2010
Actual Primary Completion Date	January 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 80 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00509678
Other Study ID Numbers ICMJE	U3081n
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Swedish Medical Center
Study Sponsor ICMJE	Swedish Medical Center
Collaborators ICMJE	Genentech, Inc.
Investigators ICMJE	Principal Investigator: Philip J Mease, MD Seattle Rheumatology Associates/ Swedish Research Center
PRS Account	Swedish Medical Center
Verification Date	January 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP