Genetic Registry for Rheumatoid Arthritis (NARAC)

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

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

Arthritis Foundation

Information provided by (Responsible Party):

Peter Gregersen, Feinstein Institute for Medical Research

ClinicalTrials.gov Identifier:

NCT00069472

First received: September 25, 2003

Last updated: April 18, 2013

Last verified: April 2013

History of Changes

Purpose

Many genes are thought to contribute to rheumatoid arthritis (RA). This study will attempt to identify genes that may contribute to RA.

Condition
Rheumatoid Arthritis

Study Type:	Observational
Study Design:	Observational Model: Family-Based Time Perspective: 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 North Shore Long Island Jewish Health System:

Primary Outcome Measures:

Genetic Association with risk for rheumatoid arthritis [ Time Frame: 3 years ] [ Designated as safety issue: No ]
The project aims to identify one or more risk alleles for rheumatoid arthritis using association methods in trio families, combeined with data from singleton cases and multiplex families

Biospecimen Retention: Samples With DNA

DNA, plasma, serum and cells

Estimated Enrollment:	3000
Study Start Date:	October 2002
Estimated Study Completion Date:	July 2015
Estimated Primary Completion Date:	July 2013 (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 enrolls people diagnosed with with RA and their families.

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

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
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
Feinstein Institute for Medical Research
Manhasset, New York, United States, 11030

Sponsors and Collaborators

North Shore Long Island Jewish Health System

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:

NARAC TRIO STUDY 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.

Eyre S, Bowes J, Diogo D, Lee A, Barton A, Martin P, Zhernakova A, Stahl E, Viatte S, McAllister K, Amos CI, Padyukov L, Toes RE, Huizinga TW, Wijmenga C, Trynka G, Franke L, Westra HJ, Alfredsson L, Hu X, Sandor C, de Bakker PI, Davila S, Khor CC, Heng KK, Andrews R, Edkins S, Hunt SE, Langford C, Symmons D; Biologics in Rheumatoid Arthritis Genetics and Genomics Study Syndicate; Wellcome Trust Case Control Consortium, Concannon P, Onengut-Gumuscu S, Rich SS, Deloukas P, Gonzalez-Gay MA, Rodriguez-Rodriguez L, Ärlsetig L, Martin J, Rantapää-Dahlqvist S, Plenge RM, Raychaudhuri S, Klareskog L, Gregersen PK, Worthington J. High-density genetic mapping identifies new susceptibility loci for rheumatoid arthritis. Nat Genet. 2012 Dec;44(12):1336-40. doi: 10.1038/ng.2462. Epub 2012 Nov 11.

Raychaudhuri S, Sandor C, Stahl EA, Freudenberg J, Lee HS, Jia X, Alfredsson L, Padyukov L, Klareskog L, Worthington J, Siminovitch KA, Bae SC, Plenge RM, Gregersen PK, de Bakker PI. Five amino acids in three HLA proteins explain most of the association between MHC and seropositive rheumatoid arthritis. Nat Genet. 2012 Jan 29;44(3):291-6. doi: 10.1038/ng.1076.

Gregersen PK, Amos CI, Lee AT, Lu Y, Remmers EF, Kastner DL, Seldin MF, Criswell LA, Plenge RM, Holers VM, Mikuls TR, Sokka T, Moreland LW, Bridges SL Jr, Xie G, Begovich AB, Siminovitch KA. REL, encoding a member of the NF-kappaB family of transcription factors, is a newly defined risk locus for rheumatoid arthritis. Nat Genet. 2009 Jul;41(7):820-3. doi: 10.1038/ng.395. Epub 2009 Jun 7.

Remmers EF, Plenge RM, Lee AT, Graham RR, Hom G, Behrens TW, de Bakker PI, Le JM, Lee HS, Batliwalla F, Li W, Masters SL, Booty MG, Carulli JP, Padyukov L, Alfredsson L, Klareskog L, Chen WV, Amos CI, Criswell LA, Seldin MF, Kastner DL, Gregersen PK. STAT4 and the risk of rheumatoid arthritis and systemic lupus erythematosus. N Engl J Med. 2007 Sep 6;357(10):977-86.

Responsible Party:	Peter Gregersen, Center Head, Robert S Boas Center for Genomics and Human Genetics, Feinstein Institute for Medical Research
ClinicalTrials.gov Identifier:	NCT00069472 History of Changes
Other Study ID Numbers:	NIAMS-107, N01AR072232-001
Study First Received:	September 25, 2003
Last Updated:	April 18, 2013
Health Authority:	United States: Federal Government

Keywords provided by North Shore Long Island Jewish Health System:

Genetics

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases

Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013

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