Condition category
Musculoskeletal Diseases
Date applied
01/09/2006
Date assigned
21/12/2006
Last edited
21/12/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Josef Smolen

ORCID ID

Contact details

Medical University of Vienna
Waehringer Guertel 18-20
Vienna
1090
Austria
+43 (0) 1 40 400 4381
josef.smolen@wienkav.at

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.1

Study information

Scientific title

Acronym

RIPA

Study hypothesis

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

Ethical committee and internal review board of the Medical University of Vienna (reference number 049/2006), date of approval: 14/03/2006.

Study design

A multi-centre placebo-controlled, double blind randomized study of Rituximab (MabThera®) in patients with active Psoriatic Arthritis

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Psoriatic Arthritis (PsA)

Intervention

Infusion with Rituximab (MabThera®)

Intervention type

Drug

Phase

Phase II/III

Drug names

Rituximab (MabThera®), methotrexate (MTX)

Primary outcome measures

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.

Secondary outcome measures

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)

Overall trial start date

01/09/2006

Overall trial end date

01/09/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant 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

Recruitment start date

01/09/2006

Recruitment end date

01/09/2007

Locations

Countries of recruitment

Austria

Trial participating centre

Medical University of Vienna
Vienna
1090
Austria

Sponsor information

Organisation

Medical University of Vienna (Austria)

Sponsor details

c/o Prof. Dr. Josef Smolen
Waehringer Guertel 18-20
Vienna
1090
Austria
+43 (0) 1 40 400 4381
josef.smolen@wienkav.at

Sponsor type

University/education

Website

http://www.meduniwien.ac.at/

Funders

Funder type

Other

Funder name

The trial is an investigator driven study without any grant support, Roche provides the medication.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes