Genetic Registry for Rheumatoid Arthritis - Full Text View

Sponsor:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator:	Arthritis Foundation
Information provided by:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:	NCT00069472

Purpose

Many genes are thought to contribute to rheumatoid arthritis (RA). Currently only one such gene has been identified. This study will attempt to identify all of the genes that may contribute to RA and determine which specific genetic variations are responsible for the disease.

Condition
Rheumatoid Arthritis

Study Type:	Observational
Study Design:	Family-Based, Cross-Sectional
Official Title:	Genetics of Rheumatoid Arthritis Registry

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Biospecimen Retention: Samples With DNA

Biospecimen Description:

DNA, plasma, serum and cells

Estimated Enrollment:	3000
Study Start Date:	October 2002
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Detailed Description:

The identification of genes for complex disorders such as RA requires large numbers of genetically informative families. This study will enroll patients with RA and their families.

This study will enroll 1000 RA patients and their parents. Participants with RA will be evaluated by a study official at his or her doctor's office or other location convenient for the participant. Participants will have a brief interview and physical exam and a blood sample will be obtained. Disease evaluation will be done at one visit and will include a 28 joint count, joint alignment and mobility score (JAMS), administration of a health assessment questionnaire and other related questionnaires. Physician confirmation of diagnosis will also be included in the disease evaluation.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Persons with RA who have two living biological parents. Parents can be affected or unaffected with RA. We call the family units "trios".

Criteria

Inclusion Criteria:

Adult onset RA, RF positive or anti-CCP positive
Diagnosis of RA made between 18 and 60 years old
Both parents alive and willing to participate
Parents may have diagnosis of RA (affected) or be unaffected

Exclusion Criteria:

Inflammatory bowel disease
Lupus
Psoriatic arthritis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00069472

Locations

United States, New York
North Shore Long Island Jewish Research Institute	Recruiting
Manhasset, New York, United States, 11030
Contact: Marlena Kern, RN 800-382-4827 mkern@nshs.edu

Sponsors and Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Arthritis Foundation

Investigators

Principal Investigator:

Peter K. Gregersen, MD

North Shore University Hospital

More Information

Additional Information:

Click here for the North American Rheumatoid Arthritis Consortium Web site (current study data, publications, and registry contact information) This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Jawaheer D, Li W, Graham RR, Chen W, Damle A, Xiao X, Monteiro J, Khalili H, Lee A, Lundsten R, Begovich A, Bugawan T, Erlich H, Elder JT, Criswell LA, Seldin MF, Amos CI, Behrens TW, Gregersen PK. Dissecting the genetic complexity of the association between human leukocyte antigens and rheumatoid arthritis. Am J Hum Genet. 2002 Sep; 71(3): 585-94. Epub 2002 Aug 09.

Jawaheer D, Seldin MF, Amos CI, Chen WV, Shigeta R, Monteiro J, Kern M, Criswell LA, Albani S, Nelson JL, Clegg DO, Pope R, Schroeder HW Jr, Bridges SL Jr, Pisetsky DS, Ward R, Kastner DL, Wilder RL, Pincus T, Callahan LF, Flemming D, Wener MH, Gregersen PK. A genomewide screen in multiplex rheumatoid arthritis families suggests genetic overlap with other autoimmune diseases. Am J Hum Genet. 2001 Apr; 68(4): 927-36. Epub 2001 Mar 09.

Jawaheer D, Seldin MF, Amos CI, Chen WV, Shigeta R, Etzel C, Damle A, Xiao X, Chen D, Lum RF, Monteiro J, Kern M, Criswell LA, Albani S, Nelson JL, Clegg DO, Pope R, Schroeder HW Jr, Bridges SL Jr, Pisetsky DS, Ward R, Kastner DL, Wilder RL, Pincus T, Callahan LF, Flemming D, Wener MH, Gregersen PK; North American Rheumatoid Arthritis Consortium. Screening the genome for rheumatoid arthritis susceptibility genes: a replication study and combined analysis of 512 multicase families. Arthritis Rheum. 2003 Apr; 48(4): 906-16.

Responsible Party:	The Feinstein Institute for Medical Research ( Peter K Gregersen, MD )
Study ID Numbers:	NIAMS-107
Study First Received:	September 25, 2003
Last Updated:	May 5, 2009
ClinicalTrials.gov Identifier:	NCT00069472 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Genetics

Additional relevant MeSH terms:

Autoimmune Diseases
Immune System Diseases
Musculoskeletal Diseases
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 27, 2009