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Suppression of the Growth Hormone/ Insulin-Like Growth Factor-1 (GH/IGF-1) Axis in Women With Rheumatoid Arthritis

Phase 2
Not Enrolling
Rheumatoid Arthritis, Healthy

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Trial Information

Suppression of the Growth Hormone/ Insulin-Like Growth Factor-1 (GH/IGF-1) Axis in Women With Rheumatoid Arthritis

This is a study in pre-menopausal and perimenopausal women with onset of rheumatoid
arthritis (RA) of less than 10 years duration, to be conducted at the Clinical Center of
National Institutes of Health and The General Clinical Research Center of the Johns Hopkins
Bayview Medical Center, Baltimore, MD. This investigation will explore the possible impact
of systemically released inflammatory cytokines on suppression of the GH/IGF-1 axis, and the
relationships of altered endocrine-immune function with body composition, endocrine,
metabolic and vascular functions thought to be associated with RA-related sarcopenia,
osteopenia and increased cardiovascular risk. In phase I of the study, we shall admit RA
patients and control subjects to the Clinical Center for a 26-36 hour period for assessments
of the GH/IGF-I axis, cytokines, body composition, endocrine-metabolic and cardiovascular
functions, and quality of life. We plan to initiate Phase I of the study to compare
baseline endocrine and inflammatory parameters in RA patients to matched normal controls.
Phase II of the study, we shall enroll a new group of RA patients to evaluate the above
outcome measures at baseline and after six months of treatment with standard therapy, using
the soluble p75 TNF receptor molecule etanercept, that has recently been approved by the FDA
for the treatment of patients with early RA. Phase 2 of this study will be initiated upon
access to etanercept and completion of Phase I of the study.

Inclusion Criteria


Healthy women, or women with RA, 18-55 year old, with a history of regular menses or who
are perimenopausal, have a BMI less than 30, able to provide informed consent to all
aspects of the study after full information is provided.

Women must have a negative pregnancy test at screening.

Study participants will be allowed to continue taking medications for chronic, stable
conditions, such as hypertension and hypercholesteremia, while in the study.


Active RA as defined by 9 tender and 6 swollen joints; ESR greater than 35 mm/hr OR CRP
greater than 2.0 mg/dL; and, morning stiffness greater than 45 min.

Actively menstruating with a normal estrogen level or who are perimenopausal.

Women must be practicing, or willing to practice, an acceptable method of birth control
that does not involve use of prescription or OTC estrogen/progesterone preparations during
the two weeks prior to screening. Acceptable means of contraception include: abstinence,
barrier methods with spermicides, intrauterine devices (IUD's) or surgical sterilization.
(phase 2 of the study only)

Current use of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or hydroxychloroquine are
permitted. Drug doses must have been stable for at least one month prior to enrollment,
and must be held constant during the study unless toxicity requires dose reduction.

Past use of a disease modifying agent (DMARD) such as methotrexate, sulfasalazine and
cyclosporine is allowed.


Patients or control subject will be excluded if they exhibit any medical condition that
has the potential of placing the candidate at unnecessary risk during the study.
Additionally, patients with impaired renal, hepatic, cardiovascular or endocrine-metabolic
function, or any immunodeficiency syndrome including HIV infection, will be excluded

Use of systemic corticosteroids in the two weeks before screening and study entry.

Women with a history of cancer, with the exception of limited, resolved skin cancer.

Women who are menopausal. Clinical menopause is defined as the absence of spontaneous
menses during the preceding 12 months.

Pregnant women or women who are nursing.

Use of prescription or OTC estrogen/progesterone preparations during the two weeks prior
to screening

The patient or control subject has received any investigational drug within 30 days of the
start of the study.

History of autoimmune endocrinopathy.

Serious medical illnesses or abnormal laboratory values that would, in the opinion of the
P.I., preclude study participation.


BMI greater than or equal to 30.

Active infection or other contraindication to use of an anti-TNF agent (phase 2 of the
study only).

History of untreated tuberculosis, or of a positive PPD without completion of adequate
treatment. (phase 2 of the study only)

Live vaccinations in the 3 months prior to study (phase 2 of the study only).

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment


United States: Federal Government

Study ID:




Start Date:

April 2002

Completion Date:

December 2005

Related Keywords:

  • Rheumatoid Arthritis
  • Healthy
  • Cytokines
  • Exanercept
  • Cachexia
  • Body Composition
  • Vascular Endothelial System
  • Rheumatoid Arthritis
  • RA
  • Women
  • Healthy Volunteer
  • HV
  • Normal Control
  • Arthritis
  • Arthritis, Rheumatoid



National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Bethesda, Maryland  20892