- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00006292
Infliximab for the Treatment of Early Rheumatoid Arthritis
Randomized Double Blind Active Treatment Controlled Trial of the Anti-TNF-Alpha Antibody Infliximab in Patients With Erosive Rheumatoid Arthritis
This study will test whether the drug combination of methotrexate and infliximab (anti-TNF-alpha antibody) is more effective than methotrexate alone for treating rheumatoid arthritis early in the disease. (The Food and Drug Administration has approved both treatment regimens for patients with long-standing rheumatoid arthritis.) The study will also evaluate how effectively magnetic resonance imaging (MRI) can detect differences in the development of bone damage in the two treatment groups by as early as 6 months.
Patients 18 years of age and older who have had rheumatoid arthritis for less than 2 years and who have four or more affected joints may be eligible for this 1-year study. Patients must have received methotrexate treatment in the past without complete success, and must not have been treated previously with Anti-Thymocyte therapy.
All participants will receive 20 Mg./week of methotrexate. In addition, patients will be randomly assigned to receive a monthly infusion of infliximab or placebo (a fluid that contains no active drug). After 6 months, all patients will receive active infliximab for the remaining half year of the study. Patients will also receive folic acid (1mg/day), Vitamin D (400 IU/day), and calcium supplements. They may continue to take prednisone (no more than 10 Mg./day) and non-steroidal anti-inflammatory drugs (NSAIDS). Medication dosages will be adjusted as needed if pain and joint swelling worsen. Over the course of the study, patients will come to NIH for 15 visits and undergo the following tests and procedures:
- Joint examination-at every visit.
- Drug side effects evaluation-at every visit during the study and after the study at 24 and 36 months by questionnaires to be filled out and returned.
- Hand and feet X-rays at the first visit, at 6 months and at 12 months.
- MRIs of the wrist to examine damage in the bone and synovial tissue (tissue lining the joint)-before treatment begins and at weeks 15, 27 and 54. For this study, the patient lies still in a narrow cylinder (the scanner) with a strong magnetic field. A contrast material (gadolinium) is injected into the blood to enhance the images of the synovium. The MRI takes about 45 minutes.
- DEXA scans (dual emission X-ray absorptiometry) of the lower spine, one hip and one wrist to measure bone density and assess bone loss-before treatment begins and at weeks 27 and 54. This X-ray test takes about 5 to 10 minutes.
- CTs (computed tomography) of one hand to assess joint damage in the wrist-before treatment begins and at weeks 27 and 54. Only half the patients in the study will have this X-ray study, which produces 3-dimensional images of the hand. It will be done to compare the location, size and change of damage in the wrist seen on CT with the information obtained on MRI. The procedure takes about 5 to 10 minutes to complete.
- Blood tests-at every visit to evaluate treatment response and side effects.
Descripción general del estudio
Descripción detallada
Tipo de estudio
Inscripción
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Maryland
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Bethesda, Maryland, Estados Unidos, 20892
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
Colaboradores e Investigadores
Publicaciones y enlaces útiles
Publicaciones Generales
- Hakala M, Nieminen P, Manelius J. Joint impairment is strongly correlated with disability measured by self-report questionnaires. Functional status assessment of individuals with rheumatoid arthritis in a population based series. J Rheumatol. 1994 Jan;21(1):64-9.
- Scott DL, Coulton BL, Popert AJ. Long term progression of joint damage in rheumatoid arthritis. Ann Rheum Dis. 1986 May;45(5):373-8. doi: 10.1136/ard.45.5.373.
- Hochberg MC. Early aggressive DMARD therapy: the key to slowing disease progression in rheumatoid arthritis. Scand J Rheumatol Suppl. 1999;112:3-7. doi: 10.1080/030097499750042227.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 000220
- 00-AR-0220
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