NCT00069472

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,062

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2003

Completed
11.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

September 10, 2015

Status Verified

September 1, 2015

Enrollment Period

12.8 years

First QC Date

September 25, 2003

Last Update Submit

September 9, 2015

Conditions

Rheumatoid Arthritis

Keywords

Genetics

Outcome Measures

Primary Outcomes (1)

  • Genetic Association with risk for rheumatoid arthritis

    The project aims to identify risk alleles for rheumatoid arthritis using association methods in trio families, combined with data from singleton cases and multiplex families

    10 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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".

You may qualify if:

  • 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

You may not qualify if:

  • Inflammatory bowel disease
  • Lupus
  • Psoriatic arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Feinstein Institute for Medical Research

Manhasset, New York, 11030, United States

Location

Related Publications (8)

  • 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. doi: 10.1086/342407. Epub 2002 Aug 9.

    PMID: 12181776BACKGROUND

  • 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. doi: 10.1086/319518. Epub 2001 Mar 9.

    PMID: 11254450BACKGROUND

  • 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. doi: 10.1002/art.10989.

    PMID: 12687532BACKGROUND

  • 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, Arlsetig L, Martin J, Rantapaa-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.

    PMID: 23143596BACKGROUND

  • 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.

    PMID: 22286218BACKGROUND

  • 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.

    PMID: 19503088BACKGROUND

  • Plenge RM, Seielstad M, Padyukov L, Lee AT, Remmers EF, Ding B, Liew A, Khalili H, Chandrasekaran A, Davies LR, Li W, Tan AK, Bonnard C, Ong RT, Thalamuthu A, Pettersson S, Liu C, Tian C, Chen WV, Carulli JP, Beckman EM, Altshuler D, Alfredsson L, Criswell LA, Amos CI, Seldin MF, Kastner DL, Klareskog L, Gregersen PK. TRAF1-C5 as a risk locus for rheumatoid arthritis--a genomewide study. N Engl J Med. 2007 Sep 20;357(12):1199-209. doi: 10.1056/NEJMoa073491. Epub 2007 Sep 5.

    PMID: 17804836BACKGROUND

  • 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. doi: 10.1056/NEJMoa073003.

    PMID: 17804842BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

DNA, plasma, serum and cells

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Peter K. Gregersen, MD

    North Shore University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Center Head, Robert S Boas Center for Genomics and Human Genetics

Study Record Dates

First Submitted

September 25, 2003

First Posted

September 29, 2003

Study Start

October 1, 2002

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

September 10, 2015

Record last verified: 2015-09

Locations

US(1)