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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 19 March 2012
Main ID:  EUCTR2005-001633-14-DK
Date of registration: 30/06/2005
Prospective Registration: Yes
Primary sponsor: Hvidovre Hospital, Dept. Rheumatology
Public title: Randomised, multi-center, open-label, parallel-group study comparing adalimumab (Humira?) 40 mg s.c. eow versus infliximab (Remicade?) 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
Scientific title: Randomised, multi-center, open-label, parallel-group study comparing adalimumab (Humira?) 40 mg s.c. eow versus infliximab (Remicade?) 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
Date of first enrolment: 17/08/2005
Target sample size: 112
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001633-14
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: yes Single blind: Double blind: Parallel group: yes Cross over: Other: If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no  
Phase: 
Countries of recruitment
Denmark Sweden
Contacts
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Key inclusion & exclusion criteria
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 at the discretion of the investigator
•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)



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Rheumatoid arthritis
Intervention(s)

Trade Name: Humira
Product Name: Humira
Pharmaceutical Form: Injection*

Trade Name: Remicade
Product Name: Remicade
Pharmaceutical Form: Injection*

Primary Outcome(s)
Main Objective: To establish whether RA patients with moderate to severe disease activity with an unsustainable clinical response to infliximab 3 mg/kg every 8. week are provided better long-term treatment efficacy with adalimumab 40 mg s.c. eow as compared to infliximab 3 mg/kg i.v. every 6. week. Moreover, the study should establish whether switching infliximab patients with fading clinical response to adalimumab is more cost-efficacious than continuing infliximab Rx at shorter treatment intervals.
Primary objective:
• Proportion of patients achieving combined good or moderate EULAR responses at week 24
Primary end point(s): Proportion of patients achieving combined good or moderate EULAR responses at week 24.
Secondary Objective: Proportion of patients at week 2, 6, 12, 18 and week 24 with good and moderate EULAR response. Proportion of patients with ACR20/50/70 response at week 2, 6, 12, 18 and week 24. Changes in HAQ assessment from baseline at week 2, 6, 12, 18 and week 24. Proportion of patients at week 24 with HAQ score of 0 (zero). Changes in QoL (SF-36) assessment from baseline at week 12 and week 24. Proportion of patients with ANAs, dsDNA, and Human Anti-Chimeric Antibodies (HACA) at baseline and week 24. Proportion of patients with elevated plasma VEGF, serum YKL-40 and plasma IL-6 at baseline and week 2, 6, 12, 18 and week 24. Changes in number and/or dosage of concomitant medication of DMARDs, NSAIDs, and corticosteroids. Changes in all of the above mentioned endpoints when stratified for presence of HACAs at baseline.
Secondary Outcome(s)
Secondary ID(s)
HUM 05-001
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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