Rituximab In Psoriatic Arthritis: a multi-centre randomised placebo-controlled double blind pilot-study of rituximab in patients with active psoriatic arthritis

ISRCTN	ISRCTN76859006
DOI	https://doi.org/10.1186/ISRCTN76859006
Protocol serial number	1.1
Sponsor	Medical University of Vienna (Austria)
Funder	The trial is an investigator driven study without any grant support, Roche provides the medication.

Submission date: 01/09/2006
Registration date: 21/12/2006
Last edited: 21/12/2006

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Josef Smolen
Scientific

Medical University of Vienna
Waehringer Guertel 18-20
Vienna
1090
Austria

Phone	+43 (0) 1 40 400 4381
Email	josef.smolen@wienkav.at

Study information

Primary study design	Interventional
Study design	A multi-centre placebo-controlled, double blind randomized study of Rituximab (MabThera®) in patients with active Psoriatic Arthritis
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	RIPA
Study objectives	To investigate the efficacy and safety of treatment with rituximab in patients with active Psoriatic Arthritis (PsA) who showed at last one Disease Modifying Anti-Rheumatic Drug (DMARD) failure (phase IIb, efficacy and dose finding).
Ethics approval(s)	Ethical committee and internal review board of the Medical University of Vienna (reference number 049/2006), date of approval: 14/03/2006.
Health condition(s) or problem(s) studied	Psoriatic Arthritis (PsA)
Intervention	Infusion with Rituximab (MabThera®)
Intervention type	Drug
Phase	Phase II/III
Drug / device / biological / vaccine name(s)	Rituximab (MabThera®), methotrexate (MTX)
Primary outcome measure(s)	Primary endpoint is the Psoriatic Arthritis Response Criteria (PsARC): improvement of 30% of tender and swollen joint count or if only one fulfilled, then plus 30% improvement of Visual Analogue Scale (VAS) patient global or physican global.
Key secondary outcome measure(s)	1. Psoriasis Area and Severity Index 2. Disease Activity Score based on 28 joints (DAS28) 3. Simplified Disease Activity Index (SDAI) 4. Clinical Disease Activity Index (CDAI) 5. Disease Activity index for the assessment of Reactive Arthritis (DAREA) 6. Health Assessment Questionnaire (HAQ) 7. Short Form health survey (SF-36)
Completion date	01/09/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	40
Key inclusion criteria	1. Patients diagnosed with PsA according to the following criteria: psoriasis or family history of psoriasis plus any one of the following criteria: a. clinical inflammatory enthesitis b. radiographic enthesitis c. distal interphalangeal joint disease d. sacroiliitis or spinal inflammation e. dactylitis f. monoarthritis g. oligoarthritis (four or less swollen joints) 2. Aged 18 years or older 3. Negative rheumatoid factor 4. The disease should at least have been diagnosed six months prior to screening 5. Active disease at the time of screening as defined by: a. two out of the following three criteria: i. more than or equal to four swollen on a 66/68 joint count ii. more than or equal to six tender joints on a 66/68 joint count iii. presence of dactylitis b. and one out of the following two categories: i. Erythrocyte Sedimentation Rate (ESR) more than or equal to 28 mm/h ii. C-Reactive Protein (CRP) more than or equal to 1.0 mg/dl 6. Insufficient response to MTX in maximum tolerated dose 7. All patients use MTX and must be on a stable dose prior to screening 8. Patients must be receiving concurrent therapeutic folic acid 9. Patients using oral corticosteroids must have been on a stable dose of less than or equal to 10 mg/day for two weeks prior to screening. If using Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), patients must be on a stable dose for two weeks prior to screening 10. Women of childbearing potential or men capable of fathering children must be using adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, surgical sterilisation) during the study and for six months after receiving the last administration of study agent 11. Female subjects of childbearing potential must test negative for pregnancy. A pregnancy test will be performed at the beginning and at the end of the study 12. The screening laboratory test must meet the following criteria: a. haemoglobin more than or equal to 8.5 g/dl providing the low haemoglobin level is not due to other diseases than anemia of chronic inflammation b. White Blood Cells (WBC) more than or equal to 3500/µl c. neutrophils more than or equal to 1500/µl d. platelets more than or equal to 100,000/µl e. serum transaminase less than or equal to two times the Upper Limit of Normal f. serum creatinine less than or equal to 1.7 mg/dl 13. 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
Key exclusion criteria	Patients are excluded if they meet one of the following criteria: 1. Pregnant women, nursing mothers or a planned pregnancy within six months after last scheduled treatment 2. Patients with other inflammatory diseases that might interfere with the evaluation of the psoriatic arthritis 3. Patients with fibromyalgia syndrome 4. Use of Rituximab prior to screening 5. Treatment with Tumor Necrosis Factor (TNF)-Blockers prior to screening 6. Use of IntraMuscular (IM), IntraVenous (IV), Intra-Arterial (IA) corticosteroids within four weeks prior to screening 7. Treatment with any investigational drug within three months prior to screening 8. Use of cyclosporine or tacrolimus within four weeks prior to screening 9. A history of known allergy to murine proteins, e.g. allergy to Infliximab 10. History of infected joint prosthesis within the previous five years 11. Chronic infections 12. History of active TuBerculosis (TB) requiring treatment within the previous three years, or history of opportunistic infections within two months, uncontrolled active infection or documented Human Immunodeficiency Virus (HIV) infection. Also excluded are patients with evidence of latent TB and patients with old TB without documented adequate therapy if they will not be treated according to the local TB guidelines 13. Current signs or symptoms of other severe uncontrolled disease which in the investigators opinion would put the patient at an unacceptable risk 14. History of lymphoproliferative disease, any current malignancies or history of malignancy within five years other than successfully treated basal cell carcinoma or squamous cell carcinoma of the skin 15. History of drug abuse
Date of first enrolment	01/09/2006
Date of final enrolment	01/09/2007

Locations

Countries of recruitment

Austria

Study participating centre

Medical University of Vienna

Vienna
1090
Austria

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan