Rituxan With or Without Methotrexate in Psoriatic Arthritis

NCT00509678 | Completed Phase 1 DMC

• 1 other identifier: U3081n
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 4

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.

Conditions

Psoriatic Arthritis

Keywords

Rituximab; Rituxan; Psoriatic Arthritis; Arthritis

Outcome Measures

Primary Outcomes (1)

• Safety of Rituximab in PSA and psoriasis by determining incidence of treatment emergent AE's including infections, infusion reactions and disease progression.

  followed out for one year from last dose

Secondary Outcomes (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.

  Week 24

Interventions

Rituximab DRUG

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.

Also known as: Rituxan

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Swedish Medical Center: lead
• Genentech, Inc.: collaborator

Study Sites (4)

University of California, San Diego

La Jolla, California, 92037-0943, United States

Location

Stanford University

Stanford, California, 94305-5350, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Swedish Rheumatology Research

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Arthritis, Psoriatic; Arthritis

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Philip J Mease, MD

  Seattle Rheumatology Associates/ Swedish Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2007
• First Posted: July 31, 2007
• Study Start: December 1, 2006
• Primary Completion: January 1, 2010
• Study Completion: March 1, 2010
• Last Updated: January 18, 2012

Record last verified: 2012-01

Locations

US (4)