Biomaterial Database

A randomized, double-blind study comparing twenty-four-week treatment with recombinant interferon-gamma versus placebo in the treatment of rheumatoid arthritis. 1997

E M Veys, and C J Menkes, and P Emery

Department of Rheumatology, University Hospital, Gent, Belgium.

OBJECTIVE To evaluate the safety and efficacy of recombinant interferon-gamma (rIFN gamma) in patients with active rheumatoid arthritis (RA), using an induction and maintenance regimen. METHODS A multicenter, randomized, double-blind trial of 197 patients with RA was conducted to compare the effects in a group receiving 50 micrograms of rIFN gamma, given subcutaneously in a decreasing regimen over 24 weeks, with those in a placebo group receiving injections of placebo at the same time frequency. Standard clinical assessments were performed. RESULTS Both rIFN gamma and placebo produced a significant improvement from baseline to end point visit for most measurements (except erythrocyte sedimentation rate, duration of morning stiffness, and grip strength), but no significant intergroup differences were seen. Regarding adverse effects, mild local skin reactions at the site of injection were observed, and among the cardiovascular events, mild edema and vasodilatation were reported. CONCLUSIONS IFN gamma proved no more effective than placebo in this group of patients with RA. IFN gamma was well tolerated in this group of patients, without increased toxicity compared with placebo.

UI	MeSH Term	Description	Entries
D007279	Injections, Subcutaneous	Forceful administration under the skin of liquid medication, nutrient, or other fluid through a hollow needle piercing the skin.	Subcutaneous Injections,Injection, Subcutaneous,Subcutaneous Injection
D007371	Interferon-gamma	The major interferon produced by mitogenically or antigenically stimulated LYMPHOCYTES. It is structurally different from TYPE I INTERFERON and its major activity is immunoregulation. It has been implicated in the expression of CLASS II HISTOCOMPATIBILITY ANTIGENS in cells that do not normally produce them, leading to AUTOIMMUNE DISEASES.	Interferon Type II,Interferon, Immune,gamma-Interferon,Interferon, gamma,Type II Interferon,Immune Interferon,Interferon, Type II
D008297	Male		Males
D008875	Middle Aged	An adult aged 45 - 64 years.	Middle Age
D011994	Recombinant Proteins	Proteins prepared by recombinant DNA technology.	Biosynthetic Protein,Biosynthetic Proteins,DNA Recombinant Proteins,Recombinant Protein,Proteins, Biosynthetic,Proteins, Recombinant DNA,DNA Proteins, Recombinant,Protein, Biosynthetic,Protein, Recombinant,Proteins, DNA Recombinant,Proteins, Recombinant,Recombinant DNA Proteins,Recombinant Proteins, DNA
D003710	Demography	Statistical interpretation and description of a population with reference to distribution, composition, or structure.	Demographer,Demographic,Demographic and Health Survey,Population Distribution,Accounting, Demographic,Analyses, Demographic,Analyses, Multiregional,Analysis, Period,Brass Technic,Brass Technique,Demographers,Demographic Accounting,Demographic Analysis,Demographic Factor,Demographic Factors,Demographic Impact,Demographic Impacts,Demographic Survey,Demographic Surveys,Demographic and Health Surveys,Demographics,Demography, Historical,Demography, Prehistoric,Factor, Demographic,Factors, Demographic,Family Reconstitution,Historical Demography,Impact, Demographic,Impacts, Demographic,Multiregional Analysis,Period Analysis,Population Spatial Distribution,Prehistoric Demography,Reverse Survival Method,Stable Population Method,Survey, Demographic,Surveys, Demographic,Analyses, Period,Analysis, Demographic,Analysis, Multiregional,Demographic Analyses,Demographies, Historical,Demographies, Prehistoric,Distribution, Population,Distribution, Population Spatial,Distributions, Population,Distributions, Population Spatial,Family Reconstitutions,Historical Demographies,Method, Reverse Survival,Method, Stable Population,Methods, Reverse Survival,Methods, Stable Population,Multiregional Analyses,Period Analyses,Population Distributions,Population Methods, Stable,Population Spatial Distributions,Prehistoric Demographies,Reconstitution, Family,Reconstitutions, Family,Reverse Survival Methods,Spatial Distribution, Population,Spatial Distributions, Population,Stable Population Methods,Technic, Brass,Technique, Brass
D004334	Drug Administration Schedule	Time schedule for administration of a drug in order to achieve optimum effectiveness and convenience.	Administration Schedule, Drug,Administration Schedules, Drug,Drug Administration Schedules,Schedule, Drug Administration,Schedules, Drug Administration
D005260	Female		Females
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000293	Adolescent	A person 13 to 18 years of age.	Adolescence,Youth,Adolescents,Adolescents, Female,Adolescents, Male,Teenagers,Teens,Adolescent, Female,Adolescent, Male,Female Adolescent,Female Adolescents,Male Adolescent,Male Adolescents,Teen,Teenager,Youths