Juvenile Rheumatoid ArthritisNCT00004420
Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis
A study testing gamma-Linolenic acid in people with Juvenile Rheumatoid Arthritis, run by FDA Office of Orphan Products Development.
Trial summary
OBJECTIVES: I. Determine the efficacy and safety of gammalinolenic acid in the treatment of childhood arthritis. Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- Conditions the study is for
- Juvenile Rheumatoid Arthritis
- What is being tested?
- gamma-Linolenic acid
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Sep 1994to Aug 1999
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 15 years
- All sexes
- No healthy volunteers
- Child
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Juvenile rheumatoid arthritis (systemic onset, pauciarticular disease, and polyarticular disease)
- Active synovitis
--Prior/Concurrent Therapy--
- No more than 2 concurrent nonsteroidal antiinflammatory drugs
- No more than 2 concurrent second line agents (e.g., D-penicillamine, oral or injectable gold, antimalarials, methotrexate, sulfasalazine)
- Must have started second line agent at least 3 months prior to study
- Must be on stable doses of all medications for at least 1 month prior to study
- Prior prednisone allowed if started at least 3 months prior to study
About this study
OBJECTIVES:
- Determine the efficacy and safety of gammalinolenic acid in the treatment of childhood arthritis.
Read the detailed description
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, cross over study of 12 months duration. Patients are stratified by type of juvenile rheumatoid arthritis (systemic onset vs pauciarticular disease vs polyarticular disease).
Patients are randomized to receive either gammalinolenic acid (GLA) or placebo (safflower seed oil) orally. Parents are asked to maintain the child's usual diet over the course of study.
Patients are followed at 3, 6, 9, and 12 months during study and at 6 months thereafter.
- Conditions
- Juvenile Rheumatoid Arthritis
- Being tested
- gamma-Linolenic acid
- Keywords
- arthritis & connective tissue diseases, juvenile rheumatoid arthritis, rare disease
- Medical subject headings
- Arthritis, Juvenile, Arthritis, Connective Tissue Diseases, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gamma-Linolenic acidDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startSep 1994
- Study completionAug 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- FDA Office of Orphan Products Development
- Sponsor type
- US federal agency
- Collaborators
- University of Massachusetts, Worcester
- Investigators
- Robert B. Zurier, Study chair, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004420
- Sponsor's protocol ID
- 199/13314
- Other IDs
- UMASS-H-2703, UMASS-FDR001067
- Status last verified
- Jan 2000
- First submitted
- 18 Oct 1999
- Last updated
- 25 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00004420
- Acronym / sponsor ID
- 199/13314
- Conditions
- Juvenile Rheumatoid Arthritis
- Keywords
- arthritis & connective tissue diseases, juvenile rheumatoid arthritis, rare disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- FDA Office of Orphan Products DevelopmentUS federal agency
- Collaborators
- University of Massachusetts, Worcester
- Study start
- Sep 1994
- Study completion
- Aug 1999
- First posted
- 19 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES:
- Determine the efficacy and safety of gammalinolenic acid in the treatment of childhood arthritis.
Detailed description
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, cross over study of 12 months duration. Patients are stratified by type of juvenile rheumatoid arthritis (systemic onset vs pauciarticular disease vs polyarticular disease).
Patients are randomized to receive either gammalinolenic acid (GLA) or placebo (safflower seed oil) orally. Parents are asked to maintain the child's usual diet over the course of study.
Patients are followed at 3, 6, 9, and 12 months during study and at 6 months thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gamma-Linolenic acid | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert B. Zurier study chair
University of Massachusetts, Worcester
Questions about this trial
What is this clinical trial studying?
A study testing gamma-Linolenic acid in people with Juvenile Rheumatoid Arthritis, run by FDA Office of Orphan Products Development.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.