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NCT00034060 · ClinicalTrials.gov registry record · Phase 2

The Role of Cytokines on Growth Hormone Suppression in Premenopausal Women With Rheumatoid Arthritis and the Effect of Treatment With Etanercept

A Phase 2 study of Healthy and Rheumatoid Arthritis, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

Completed
Registry status
Phase 2
Development phase
36
Enrollment target
1
Study location

NCT00034060: Completed Phase 2 study of Healthy and Rheumatoid Arthritis, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

NCT00034060 is a Phase 2 study of Healthy and Rheumatoid Arthritis that has completed, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The registered enrollment target is 36 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00034060, a Phase 2 study of Healthy and Rheumatoid Arthritis, has completed, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

COMPLETED
Registry status
Phase 2
Development phase
36 participants
Enrollment target
1
Study location

Study Summary

This study has two phases. Phase 1 will examine the role of inflammatory mediators called cytokines on growth hormone levels in women with rheumatoid arthritis (RA). Phase 2 will evaluate the effect of etanercept on these growth hormone levels. Etanercept is approved for the treatment of RA. It lowers the levels of a key inflammatory mediator called tumor necrosis factor-alpha and is very effective in reducing arthritis symptoms. Growth hormone promotes bone and muscle growth. With aging, people lose muscle mass and bone strength, possibly because of decreased levels of growth hormone. People with RA have bone and muscle changes similar to those in older people, perhaps also due to decreased levels of growth hormone. The first part of this study will see if the inflammatory mediators responsible for joint inflammation (warmth, redness, pain, and swelling) in RA are related to the lowered growth hormone levels in this disease. The second part will evaluate the effect of etanercept treatment on muscle mass and bone density, in addition to growth hormone levels. Premenopausal women between 18 and 55 years of age with a recent diagnosis of rheumatoid arthritis (less than 3 years) are eligible for this study. Healthy volunteers will also be enrolled in the first phase of the study as control subjects. This study is conducted at two sites, the NIH and the Johns Hopkins Medical Center in Baltimore. Healthy volunteers enrolled in this study will be interviewed about their health status and will fill out questionnaires on diet and general physical function, including fatigue, energy and well being. In addition, they will be hospitalized once at the NIH Clinical Center for 24-hour blood sampling and will visit to Johns Hopkins Medical Center in Baltimore for a brachial artery reactivity study, as follows: * 24-hour blood sampling for growth hormone levels. Blood samples (1/2 teaspoon each) will be collected every 20 minutes from 8 AM one day until 8 AM the following day t

Conditions Studied

Healthy Rheumatoid Arthritis

Interventions

  • DRUG Etanercept

Study Locations (1)

Maryland

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) - Bethesda

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2002-04
Est. Completion 2005-12
Phase Phase 2
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

93 total trials

What the finished NCT00034060 record still lists

NCT00034060 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (94% lower).

The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which Etanercept is the first listed.

NCT00034060 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT00034060 about?

NCT00034060 is a clinical study titled "The Role of Cytokines on Growth Hormone Suppression in Premenopausal Women With Rheumatoid Arthritis and the Effect of Treatment With Etanercept". This study has two phases. Phase 1 will examine the role of inflammatory mediators called cytokines on growth hormone levels in women with rheumatoid arthritis (RA). Phase 2 will evaluate the effect of etanercept on these growth hormone levels. Etanercept is approved for the treatment of RA. It lowe...

What is the current status of trial NCT00034060?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2002-04. Estimated completion is 2005-12.

What conditions does trial NCT00034060 study?

This clinical trial studies the following conditions: Healthy, Rheumatoid Arthritis.

What interventions are being tested in trial NCT00034060?

The interventions under investigation include: Etanercept (DRUG).

Who is sponsoring clinical trial NCT00034060?

This trial is sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00034060 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Healthy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00034060's enrollment target sits among peer trials

36 595th of 1090 higher than 469 of 1,090 other Healthy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00034060, the US trial registry maintained by the National Library of Medicine. NCT00034060 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.