Induction of Remission in RA Patients at Low Disease Activity by Additional Infliximab Therapy (Study P04644AM1) (TERMINATED)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00521924
• Date of registration: 27/08/2007
• Primary sponsor: Schering-Plough
• Public title: Induction of Remission in RA Patients at Low Disease Activity by Additional Infliximab Therapy (Study P04644AM1) (TERMINATED)
• Scientific title: Induction of Remission in RA Patients at Low Disease Activity by Additional Infliximab-therapy
• Date of first enrolment: June 2007
• Target sample size: 8
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00521924
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Austria

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients aged >35 and <=65 years with a diagnosis of rheumatoid arthritis (RA)
according to American College of Rheumatology (ACR) criteria for at least 1 year and
no more than 10 years prior to start of therapy; have active disease (Disease
Activity Score [DAS] 28 >2.8 and <3.5), with changes in the DAS 28 score <0.6 within
the 6 weeks before inclusion; have stable RA basic therapy according to standard
criteria for at least 3 months; have a chest X-ray within 1 month prior to first
infusion with no evidence of malignancy, infections, or fibrosis; and have screening
laboratory test results that meet prespecified criteria. Patient must have at least
one swollen joint. Patient must have evidence of erosive disease by x-ray at
baseline.

Exclusion Criteria:

- Patients were excluded if they met any of the following criteria:

- Women who are pregnant, nursing, or planning pregnancy within 15 months after
screening (i.e., approximately 6 months following last infusion);

- Use of any investigational drug within 1 month prior to screening or within 5
half-lives of the investigational agent, whichever is longer;

- History of any other therapeutic agent targeted at reducing tumor necrosis
factor (TNF);

- History of previous administration of infliximab;

- History of receiving human/murine recombinant products or has a known allergy to
murine products;

- Serious infection (such as hepatitis, pneumonia or pyelonephritis) in the
previous 3 months. Less serious infections (such as acute upper respiratory
tract infection [colds] or simple urinary tract infection) need not be
considered exclusions at the discretion of the investigator.

- Active tuberculosis (TB) or evidence of latent TB (positive purified protein
derivative [PPD] skin test, a history of old or latent TB or chest X-ray without
adequate therapy for TB initiated prior to first infusion of study drug), or
evidence of an old or latent TB infection without documented adequate therapy.
Patients with a current close contact with an individual with active TB and
patients who have completed treatment for active TB within the previous 2 years
are explicitly excluded from the trial. Patients with a household member who has
a history of active pulmonary TB should have had a thorough evaluation for TB
prior to study enrollment as recommended by a local infectious disease
specialist or published local guidelines of TB control agencies.

- Hepatitis B surface antigen or Hepatitis C (HCV) antibody positive; documented
Human Immunodeficiency Virus (HIV) infection;

- Have an opportunistic infection, including but not limited to evidence of active
cytomegalovirus, active pneumocystis carinii, aspergillosis, or atypical
mycobacterium infection, etc, within the previous 6 months;

- Have current signs or symptoms of severe, progressive or uncontrolled renal,
hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac,
psychiatric, neurologic, or cerebral disease (including demyelinating diseases
such as multiple sclerosis);

- Concomitant congestive heart failure >= New York Heart Association (NYHA) II;

- Have a transplanted organ (with the exception of a corneal transplant >3 months
prior to screening);

- Fibromyalgia;

- Malignancy within the past 5 years (except for squamous or basal cell carcinoma
of the skin that has been treated with no evidence of recurrence);

- History of lymphoproliferative disease including lymphoma, or signs and symptoms
suggestive of possible lymphoproliferative disease, such as lymphadenopathy of
unusual size or location (such as nodes in the posterior triangle of the neck,
infraclavicular, epitrochlear, or peri-aortic areas), or splenomegaly; or

- Known recent substance abuse (drug or alcohol).



Age minimum: 19 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Biological: infliximab

Drug: DMARDs (methotrexate; chloroquine; leflunomidum; cyclosporin A; sulfasalazine; OM 89.

Primary Outcome(s)

Number of Patients in Remission According to Disease Activity Score (DAS) 28 (< 2.6) [Time Frame: after 38 weeks]

Secondary Outcome(s)

DAS 28 at Baseline vs at Week 38; Quality of Life; American College of Rheumatology (ACR) Response Disease Progression (X-ray); Effect of Inflammatory Markers on Response and Disease Progression; Assess Simplified Disease Activity Index (SDAI). [Time Frame: Weeks 14, 38, and 62]

Secondary ID(s)

2005-004530-40

P04644

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

AESCA Pharma GmbH