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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: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00006292
Date of registration: 23/09/2000
Prospective Registration: Yes
Primary sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Public title: Infliximab for the Treatment of Early Rheumatoid Arthritis
Scientific title: Randomized Double Blind Active Treatment Controlled Trial of the Anti-TNF-Alpha Antibody Infliximab in Patients With Erosive Rheumatoid Arthritis
Date of first enrolment: September 2000
Target sample size: 60
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00006292
Study type:  Interventional
Study design:  Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Key inclusion & exclusion criteria

INCLUSION CRITERIA:

Men or non-pregnant, non-breastfeeding women able to provide infomed consent to all
aspects of the study after full information is provided.

Women of childbearing age practicing effective birth control using either abstinence,
birth control pills, barrier methods with spermicides, intrauterine devices (IUD's), Depot
provera or surgical sterilization. All must test negative on a pregnancy test.

Men should practice birth control while on study.

At least 18 years of age.

No radiographic evidence of osteoarthritis in hands, feet, or knees.

Evidence of active wrist disease.

Active synovitis involving 4 or more swollen joints and all of the following: (a)
evidence of radiographic erosion in either hands or feet, or MRI erosion in the clinically
most severely involved hand; (b) tenderness or pain on movement of at least 4 joints; (c)
45 minutes of morning stiffness in the peripheral joints; (d) elevated acute phase
reactants (ESR greater than 20 mm/hr or CRP greater than 0.8 mg/dl).

All patients enrolled must have an incomplete response to methotrexate at a dosage of at
least 12.5 mg/week and a maximum of 15 mg/week orally for a minimum of 6 weeks. They
should not have been on higher methotrexate doses than 15 mg/week in the last year prior
to study entry. No other disease modifying antirheumatic drugs will be allowed while on
study. Patients on DMARDS other than MTX will have DMARDs withdrawn at least 2 weeks
prior to trial initiation. Patients are allowed to take prescription doses of FDA
approved non-steroidal anti-inflammatory drugs including selective Cox-2 inhibitors.
Patients enrolling should be on stable NSAID doses for at least 4 weeks.

Stable dose of prednisone (or equivalent amount of any other corticosteroid) equal or less
than 10 mg/day for at least four weeks. If currently not on corticosteroids, patients
must not have been using them for four weeks.

EXCLUSION CRITERIA:

Pregnant women, nursing mothers, or women of childbearing age not practicing birth
control.

Patients with other rheumatic diseases that may confound the analysis including but not
limited to Lyme disease, psoriatic arthritis, spondylarthropathy, systemic lupus
erythematosus, infectious or reactive arthritis, or Reiter's syndrome.

Fused carpal bone on CR or wrist replacement.

Having received an intra-articular steroid injection into any hand joint within four weeks
prior to the initiation of the study protocol.

MTX doses of greater than 15 mg/week orally or subcutaneously.

Previous treatment with Enbrel for greater than 4 months or have been off anti-TNF therapy
for less than 2 months before entry into protocol.

Previous treatment with infliximab.

Treatment with any monoclonal antibody in the past.

Treatment with any other investigational drug aimed to reduce synovial inflammation.

Allergy to murine derived products.

Previous history or ongoing infection with tuberculosis or pneumocystis and patients with
acute or chronic infections requiring anti-microbial therapy, serious viral infections
(e.g. hepatitis, herpes zoster, CMV or HIV) or fungal infections.

Patients having a positive PPD.

Abnormal screening labs (including LFT's greater than 2x normal).

Patients with apparent granulomas on chest x-ray.

Concomitant CHF, history of CHF or cardiomyopathy.

Concomitant demyelinating disease or history of demyelinating disease.

Confounding medical illness that in the judgement of the investigators would pose added
risk for study participants (e.g. chronic hepatic, hematologic, neurologic, renal,
pulmonary disease).

Past medical history or are currently diagnosed with any solid organ or hematologic
malignancies including lymphoproliferative diseases and leukemias.

History of substance abuse within the past 5 years.



Age minimum: N/A
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Infliximab
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
00-AR-0220
000220
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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