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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: 18 April 2012
Main ID:  EUCTR2007-003288-36-ES
Date of registration: 09/03/2010
Prospective Registration: No
Primary sponsor: Centocor BV
Public title: Ensayo clínico fase 4, multicéntrico, abierto, asesor ciego, de cambio en el cual se evalúa la eficacia y la seguridad de Infliximab (REMICADE®) en pacientes con artritis reumatoide activa que están respondiendo inadecuadamente a Etanercept (ENBREL®) o Adalimumab (HUMIRA®). - RESTART
Scientific title: Ensayo clínico fase 4, multicéntrico, abierto, asesor ciego, de cambio en el cual se evalúa la eficacia y la seguridad de Infliximab (REMICADE®) en pacientes con artritis reumatoide activa que están respondiendo inadecuadamente a Etanercept (ENBREL®) o Adalimumab (HUMIRA®). - RESTART
Date of first enrolment: 08/01/2009
Target sample size: 200
Recruitment status: Not Recruiting
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no  
Countries of recruitment
Austria Finland France Germany Netherlands Spain United Kingdom
Key inclusion & exclusion criteria
Inclusion criteria:
- Have Active RA, defined as DAS28 score =3.6, at screening visit and at baseline;
- Have =6 swollen and = 6 tender joints
- Have an inadequate response to treatment with aternecept or adalimumab, at an approved and stable dose in combination with MTX, for a minimum treatment period of at least 3 months prior to the screening visit. The last dose of adalimumab must have been administered at least 2 weeks but not more than 4 weeks prior to the first infliximab infusion. The last dose of etanercept must have been administered at least 1 week before but not more than 2 weeks before the first infliximab infusion.
- Are capable of providing written informed consent. Written informed consent must be obtained prior to performing any study-related procedures.
- Are willing and able to adhere to the study visit schedule and other protocol-specified procedures.
- Are male of female and 18 years or older
- Women of childbearing potential must test negative for pregnancy and be using birth control measures during the study and for 6 months after receiving the last administration of infliximab. Likewise, men capable of fathering children must also use appropriate methods of birth control.
- Must have decided a stable dose of = 7.5 mg/week MTX for at least 4 weeks prior to screening.
- If using NSAIDS for RA, must be on a stable dose for at least 4 weeks before screening.
- If using oral corticosteroids, must be on a stable dose equivalent to = 10 mg of prednisone/day for at least 4 weeks before screening. If currently not using corticosteroids, the patient must have not received oral corticosteroids for at least 4 weeks before screening.
- Are considered eligible according to the following TB screening criteria:
- Have no history of latent of active TB prior to screening;
- Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination;
- Have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation to rule out latent or active TB;
- Within 1month prior to the first administration of infliximab, have a negative tuberculin skin test, as outlined in Appendix A
- The screening laboratory tests must meet the following criteria:
- Hemoglobin > 8.5 g/dL
- White blood cell (WBC) count > 3.5 x 10,9 cells/L
- Neutrophils > 1.5 x 10,9 cells/L
- Platelets >100 x 10,9 cells/L
- Aspartate aminotransaminase (AST) and alanine aminotransaminase (ALT) levels must be within 2 times the upper limit of normal (ULN) for the laboratory conducting test. Alkaline phosphatase levels must be within 3 times ULN for the laboratory conducting the test.

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:
Patients meeting any of the following criteria may not be enrolled in the study:
- Have a history of latent or active granulomatous infection, including TB, histoplasmosis, of coccidioidomycosis, prior to screening, or are frequently in contact with individuals who carry active TB infection
- Had a Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening;
- Have a chest radiograph within 3 months prior to the first administration of infliximab that shows an abnormality suggestive of a malignancy of current active infection, including TB;
- Have had a nontubercolous mycobacterial infection of opportunistic infection within 6 months prior to screening;
- Have inflammatory diseases other than RA, including but not limited to Psoriatic Arthritis, Ankylosing Spondylitis, systemic lupus erythematosus, or Lyme disease, that might confound the evaluation of the benefit of infliximab therapy;
- Are receiving treatment with DMARD/systemic immunosuppressives other than MTX at screening. In patients exposed to leflunomide within the 6 months prior to the screening visit, plasma levels of leflumonide must be < 0.02 mg/L for at least 14 days before screening;
- Have ever received infliximab;
- Have ever received certolizumab pegol;
- Have received treatment with more tha 1 TNFa inhibitor;
- Have received treatment with abatacept, alefacept, efalizumab or rituximab during the 3 months prior to screening;
- Have used any investigational drug within 3 months prior to screening;
- Have or develop a concurrent disease or require medication(s) that could compromise efficacy assessments during the study;
- Have a documented HIV infection;
- Have documented current active Hepatitis B or a history of documented hepatitis C infection;
- Have shown a previous immediate hypersensitivity response, including anaphylaxis, to an immunoglobulin product;
- Have a known allergy to murine proteins or other chimeric proteins;
- Are pregnant, nursing or planning pregnancy during the trial within the 6-month period thereafter;
- Are currently participating or are likely to participate in another investigative trial using an investigational agent, procedure, or medical device during participation in this trial;
- Have a current diagnosis or a history of systemic lupus erythematous or lupus-like syndrome; severe, progressive, or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic, or cerebral diseases;
- Have a transplanted organ;
- Have had a chronic or recurrent infectious disease including but not limited to chronic renal infection; chronic chest infection; sinusitis; recurrent urinary tract infection; open, draining, of infected skin wound of ulcer;
- Have any known malignancy of history of malignancy prior to screening;
- Have multiple sclerosis or other central demeylinating disorder;
- Have a serious concomitant illness that could interfere with the patient’s participation in the trial;
- Have a history of substance abuse within the previous 3 years, history of noncompliance to medical regimens, or other condition/circumstance that could interfere with the patient’s adherence to protocol requirement;
- Have a concomitant diagnosis or any history of congestive heart failure;
- Are unable of unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access.

Age minimum:
Age maximum:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Artritis Reumatoide
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis

Trade Name: Remicade
Product Name: Remicade
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Infliximab
Other descriptive name: Chimeric Human-Murine IgG1 Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)
Main Objective: To evaluate the efficacy of infliximab at week 10 in patients with active RA who are having an inadequate response to therapy with etanercept or adalimumab.
Primary end point(s): The primary efficacy evaluation is the proportion of patients who achieve EULAR response at week 10.
Secondary Objective: To assess clinical response, physical function, and health-related quality of life through week 26 in patients with active RA who are having a inadequate response to etanercept of adalimumab.
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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