A multi-centre pilot study of Rituximab in patients with active PsA

Phase 1

• Conditions: Psoriatic Arthritis

• Registration Number: EUCTR2006-000844-17-SK
• Lead Sponsor: Vienna Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-10
• Last Update Posted: 13 March 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Inclusion criteria
-Patients diagnosed with PsA according to the following criteria: Psoriasis or family history of psoriasis plus any one of the following criteria: clinical inflammatory enthesitis, radiographic enthesitis, distal interphalangeal joint disease, sacroiliitis or spinal inflammation, uncommon arthropathies (SAPHO, spondylodiscitis, arthritis mutilans, onchyo-pachydermo-periostitis, chronic multifocal recurrent osteomyelitis), dactylitis, monoarthritis, oligoarthritis (four or less swollen joints) (7)
-Age = 18 years
-Negative rheumatoid factor
-The disease should at least have been diagnosed 6 months prior to screening
-Active disease at the time of screening as defined by
o2 out of the following 3 criteria:
?= 4 swollen on a 66/68 joint count
?= 4 tender joints on a 66/68 joint count
?Presence of dactylitis
oand 1 out of the following 2 categories
?ESR = 28 mm/ h
?CRP = 1.5 mg/ dl
-Failure of a least one DMARD, namely MTX or Leflunomide
-If patients are using one DMARD, the DMARD must be at a stable dose for at least 4 weeks prior to screening.
-Patients on MTX must be receiving concurrent therapeutic folic acid.
-Patients using oral corticosteroids must have been on a stable dose of = 10 mg/ day for 2 weeks prior to screening. If using NSAIDs, patients must be on a stable dose for two weeks prior to screening.
-Women and men of childbearing potential must be using adequate birth control measures and should continue such precautions for six months after the last infusion of Rituximab.
-The screening laboratory test must meet the following criteria:
oHemoglobin = 8.5 g/ dl providing the low hemoglobin level is not due to other diseases than anemia of chronic inflammation.
oWBC = 3500 / µl
oNeutrophils = 1500 / µl
oPlatelets = 100 000 / µl
oSerum transaminase = 2 times the upper limit of normal
oSerum creatinine = 1.7 mg/ dl
-The patient must be able to adhere the study visit schedule and other protocol requirements and must have given informed consent prior to any screening procedures.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria
Patients are excluded if they meet one of the following criteria:
-Pregnant women, nursing mothers or a planned pregnancy within six months after last scheduled treatment
-Patients with other inflammatory diseases that might interfere with the evaluation of the psoriatic arthritis.
-Patients with fibromyalgia syndrome
-Use of Rituximab prior to screening
-Use of IM, IV, IA, cortocisteroids within 4 weeks prior to screening
-Treatment with any investigational drug within 3 months prior to screening
-Use of cyclosporine or tacrolimus within 4 weeks prior to screening
-A history of known allergy to murine proteins, e.g. allergy to Infliximab
-History of infected joint prosthesis within the previous 5 years
-Chronic infections
-History of active tuberculosis requiring treatment within the previous 3 years, or history of opportunistic infections within 2 months, uncontrolled active infection or documented HIV infection. Also excluded are patients with evidence of latent tuberculosis and patients with old tuberculosis without documented adequate therapy if they will not be treated according to the local TB guidelines.
-Current signs or symptoms of other severe uncontrolled disease which in the investigators opinion would put the patient at an unacceptable risk.
-History of lymphoproliferative disease, any current malignancies or history of malignancy within 5 years other than successfully treated basal cell carcinoma or squamous cell carcinoma of the skin
-History of drug abuse
->75 years

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the safety and effectiveness of treatment with rituximab in patients with active PsA who showed at last one DMARD failure (Phase IIb, open label). ;Secondary Objective: ;Primary end point(s): Primary endpoint is the PsARC: improvement of 30% of tender and swollen joint count or if only one fulfilled, then plus 30% improvement of VAS patient global or physican global (1). <br><br>(1) Mease PJ, Goffe BS, Metz J, VanderStoep A, Finck B, Burge DJ. Etanercept in the treatment of psoriatic arthritis and psoriasis: a randomised trial. Lancet 2000; 356(9227):385-390.