EUCTR2005-001633-14-SEActive, not recruitingNot Applicable
Randomised, multi-center, open-label, parallel-group study comparing adalimumab (Humira[R]) 40 mg s.c. eow versus infliximab (Remicade[R]) 3 mg/kg i.v. every 6. week in RA patients with unsustainable clinical response to infliximab 3 mg/kg every 8. week - The SWITCH Study
Hvidovre Hospital, Dept. Rheumatology0 sites112 target enrollmentStarted: February 27, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 112
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •A subject will be eligible for study participation if he/she meets the following criteria:
- •The diagnosis of rheumatoid arthritis according to the American College of Rheumatology 1987 criteria (18)
- •Moderate or severely active RA, defined as a DAS28-3(CRP) > 3.2.
- •At least 6 months prior treatment with infliximab 3 mg/kg every 8. week with initial clinical response at the discretion of the investigator
- •Requiring incremental infliximab infusion frequency due to fading clinical response (definition based on specific criteria)
- •A negative pregnancy test (serum HCG) for women of childbearing potential prior to start of study treatment. [Non-childbearing potential is defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)]
- •Use of reliable method of contraception e.g. intra-uterine devices or hormone (oral, implantable, or injectable) contraceptives by all female patients of childbearing potential.
- •Able and willing to self-administer s.c. injections or have available a suitable person to administer s.c. injections.
- •Able and willing to give written informed consent and to comply with the requirements of the study protocol.
- •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
- •A subject will be excluded from the study if he/she meets any of the following criteria:
- •Positive serology for hepatitis B or C indicating active infection
- •History of positive HIV status
- •History of tuberculosis, histoplasmosis or listeriosis
- •Subjects with latent TB (positive PPD skin test and/or chest X-ray indicative for TB) or having other risk factors for activation of latent TB must have TB prophylaxis starting four weeks prior to the first administration of study drug in accordance with local recommendations
- •Persistent or recurrent infections or severe infections requiring hospitalisation or treatment with iv antibiotics within 30 days, or oral antibiotics within 14 days prior to enrolment
- •History of cancer or lymphoproliferative disease other than a successfully and completely treated squamous cell or basal cell carcinoma or cervical dysplasia
- •Co morbidities: uncontrolled diabetes, unstable ischemic heart disease, congestive heart failure (NYHA III-IV), active inflammatory bowel disease, recent stroke (within three months), chronic leg ulcer and any other condition (e.g. indwelling urinary catheter) which, in the opinion of the investigator, would put the subject at risk by participation in the protocol
- •Female subjects who are pregnant or breast –feeding
- •History of clinically significant drug or alcohol abuse in the last year
- •History of or current acute inflammatory joint disease of origin other than RA, e.g. mixed connective tissue disease, systemic lupus erythematosus etc. Occurrence of positive ANA and/or anti-DNA antibodies without clinical symptoms is not considered a contra-indication.
- •Previous diagnosis or signs of central nervous system demyelinating diseases (e.g. optic neuritis, visual disturbance, gait disorder/ataxia, facial paresis, apraxia)
Investigators
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