Study of peripheral enthesitis with ultrasonography doppler in spondyloarthropathies treated with infliximabESTUDIO DE LA ENTESITIS PERIFÉRICA CON ECOGRAFÍA DOPPLER EN LAS ESPONDILOARTROPATÍAS TRATADAS CON INFLIXIMAB - EUSpA

• Conditions: SpondyloarthropathiesEspondiloartropatias; MedDRA version: 9.1Level: LLTClassification code 10002556Term: Ankylosing spondylitis

• Registration Number: EUCTR2006-001579-40-ES
• Lead Sponsor: Schering-Plough France

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-04
• Last Update Posted: 12 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1-Subjects must demonstrate their willingness to participate in the study and to adhere to dose and visit schedules and comply with its procedures by signing a written informed consent and/or parent or legal guardian must have signed a written informed consent.
2-If subject is a female volunteer of childbearing potential, she must have a negative serum pregnancy test at Screening.
3-Men and women over 18 years of age of either sex, and any race.
4-Subjects must be free of any clinically relevant disease other than SpA that would, in the principal investigator’s and/or sponsor’s opinion, interfere with the conduct of the study or study evaluations;
5-Subjects must be able to adhere to the dosing and visit schedules, symptom severity scores, and agree to record medication times, concomitant medications, and adverse events (AEs) accurately and consistently in a daily diary;
6-Subjects must be elegible for anti-TNF treatment according to applicable local guidelines. For all patients chest X-ray and skin test results must be available at baseline.
7-Subjects must fulfil with the following criteria : European Spondyloarthropathy Study Group (E.S.S.G.) Classification Criteria
7.1-One of the three clinical criteria:
• Low back pain at least three month’s duration improved by exercise and not relieved by rest.
• Limitation of lumbar spine mobility in sagital and front planes.
• Chest expansion decreased relative to normal values for age and sex
7.2- One or more of the following:
Positive family history
Psoriasis
Inflammatory bowel disease
Urethritis cervicitis or acute diarrhea within or more one month before arthritis
Buttock pain alternating between right and left gluteal areas
Sacroiliitis
8-Disease duration of spondyloarthritis over 6 months
9-Incomplete response to NSAID
10-BASDAI > 4 Including Item 2 (axial pain) >= 3 on a scale from 0 to 10
11-At least one enthesitis assessed by PDUS
12-CRP 2X N or inflammatory signal on MRI of spine or sacroilliac joint
For the MRI, the inflammatory status should have been determined within the last three months
13-Subject must confirm that he/she is practicing adequate contraception:
(a) Female volunteers of childbearing potential (including women who are less than 1 year postmenopausal and women who will be sexually active during the study) must agree to use a medically accepted method of contraception or be surgically sterilized prior to screening, while receiving protocol-specified medication, and for 6 months after stopping the medication. Women who are postmenopausal for >1 year (ie, women who have experienced 12 consecutive months of amenorrhea) will be exempted from the use of contraception during the study. Acceptable methods of contraception include condoms (male and female) with a spermicidal agent, diaphragm or cervical cap with a spermicidal agent, medically prescribed intrauterine device (IUD), oral or injectable hormonal contraceptives, and surgical sterilization (eg, hysterectomy or tubal ligation).
(b) Male volunteers who are sexually active must be using an acceptable method of contraception during the study. Acceptable methods of contraception include sterilization (eg, vasectomy), condoms (male and female) with a spermicidal agent, and when having relations with a female partner, she must also practice a medically acceptable method of contraception as described in the above section. Contraception must be used during the treatment period and for 6 month receiving the last infusion,

Exclusion Criteria

A subject who meets any of the following exclusion criteria will be disqualified from participation in the study, if this subject :
1) Is a female who is pregnant, or intends to become pregnant during the study (or within 6 months after receiving the last infusion);
2) Is a female who is nursing, or intends to be nursing during the study or within 6 month after having received the last infusion;
3) Has childbearing potential without contraception throughout the study and for 6 months after receiving the last infusion.
4) Has not observed the designated washout periods for any of the prohibited medications outlined in Section 6.2;
5) Has any clinically significant deviation from the appropriate reference range in the physical examination, Chest X-ray, that, in the investigator’s judgment, may interfere with the study evaluation or affect subject safety;
6) Is in a situation or condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
7) Is on the staff, affiliated with, or a family member of the staff personnel directly involved with this study;
8) Is allergic to or has sensitivity to the study drug or its excipients;
9) Has Intolerance to or contraindication for infliximab.
10) Has an history of allergy to murine products.
11) Is uncooperative or has not signed the consent form.
12) Can not understand the protocol.
13) Has participate to a study within 3 months prior to inclusion.
14) Had treatment with unstable doses of analgesic drugs (paracetamol, phenylbutazone, morphine) steroid, NSAID, or immunosuppressive agent, including methotrexate, within 4 weeks prior to inclusion.
15) Had Intra articular steroid within 4 weeks prior to inclusion.
16) Had Previous treatment with infliximab
17)Had previous treatment with etanercept, adalimumab or any other TNF agent within 2 last months.
18) Had an history of, ongoing or recurrent medical condition as follows :
- Infectious disease, including but not limited to chronic renal infection, chronic chest infection (e.g. bronchectasis), sinusitis, recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremeting cystitis) open, draining or infected skin wound, or ulcer. Serious infection(s) (such as hepatitis, pneumonia or pyelonephritis) within 3 months prior to inclusion.
- Malignancy within the previous 5 years with the exception of basal cell carcinoma of the skin that has been treated with no evidence of recurrence.
- Active tuberculosis or previous history of non treated or insufficiently treated tuberculosis.
Patient with a positive intradermal tuberculosis test according to the local recommendation
For the patients who could have been in contact with a person having tuberculosis, the inclusion will be possible under specific conditions depending of local recommendations issued in France, Denmark, Hungary, Italy, Spain.
- Herpes zoster (shingles) infection within 2 months prior to the first infusion
- Opportunistic infections, e.g. cytomegalovirus, Pneumocystis carinii pneumonia, aspergillosis, histoplasmosis or atypical mycobacterium infection.
19) Has any of the following clinical conditions :
Severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, psychiatric, or cerebral diseases
Known to be infected with HIV, hepatitis B or hepatitis C
Known lymphoproliferative disease including lymphoma or signs suggestive of lymphoproliferative disease su

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to assess the ability of the Power Doppler Ultrasonography (PDUS) to be a reliable marker of enthesitis response and relapse in patient treated with infliximab;Secondary Objective: The secondary objectives of this study are to evaluate the patient monitoring through both clinical assessment and Power Doppler Ultrasonography during stability phase, treatment phase and follow up.;Primary end point(s): End point Criteria : Number of enthesitis between Week 4 and Week 12 evaluated using PDUS and the Imaging Data Process (IODP) software.