Study design Data collection Data analysis

French cohort of early inflammatory back pain


Study design

Data collection

Data analysis


Study design

Data collection

Data analysis


Inflammatory back pain (Berlin or Calin criteria)

Probability of spondylarthropathy >50% based on the physician’s assessment

Age >18, <50

Symptoms duration >3 months, <3years

Referral from rheumatologists, GP, … patients

Study design: Key inclusion criteria


VariablesTime of collection (month)

0 6 12 18 24 36 48 60

Patient’s assessment X X X X X X X X

Physical examination X X X X X X X X

Treatments / Co-morbidities X X X X X X X X

Physician global assessment (dg of SpA) X X X X X X X X

Laboratory assessment X X X X X X X X

Imaging X X X X

Ultrasionography (enthesis) X X X X

Bone densitometry X X X X

Calendar

Study design: Data collected



0 6 12 18 24 36 48 60

Patient’s assessment X X X X X X X XMedico-économics X X X X X X X XBASG X X X X X X X XBASDAI X X X X X X X XBASFI X X X X X X X XHAQ-AS X X X X X X X XSF36 X X X X X X X XEuro-Qol X X X X X X X X

Physical examination X X X X X X X XTreatments / Co-morbidities X X X X X X X XPhysician global (dg of SpA) X X X X X X X XLaboratory assessment X X X X X X X X

Imaging X X X X

Ultrasonography (enthesis) X X X X


Outcome measures




0 6 12 18 24 36 48 60


Physical examination X X X X X X X XWeight X X X X X X X X

Height X X X X X X X X

Blood pressure X X X X X X X X

Schober X X X X X X X X

Chest expansion X X X X X X X X

Occiput to wall X X X X X X X X

Tragus to wall X X X X X X X X

Finger to floor X X X X X X X X

Spine lateral flexion X X X X X X X XCervical spine rotation X X X X X X X XInter-maleolar distance X X X X X X X X


Physician global (dg of SpA) X X X X X X X X


Imaging X X X X

Ultrasonography (enthesis) X X X X





0 6 12 18 24 36 48 60






CRP, ESR X X X X X X X X

Cholestérol, triglycerides, glycemia X X X

B27 HLA antigen X

DNA X

RNA X* X*

Serum X X X X X

Urines X X X X X

Imaging X X X X

Ultrasonography (enthesis) X** X** X** X**

Bone densitometry X* X** X** X**


*only centers from Paris area**only centers with DEXA and/or ultrasonographs



0 6 12 18 24 36 48 60






Imaging X X X X

Plain X-rays(cervical, thoracis, lumbar, pelvis) X X X X

MRI X X* X* X*

Ultrasonography (enthesis) X* X** X** X**

Bone densitometry X** X** X** X**

*only centers from Paris area**only centers with DEXA and/or ultrasonographs



Study design

Data collection

Data analysis


Data collection

Who?

How?


Brest

Le Mans

Tours

Clermont-Ferrand

Bordeaux

Toulouse

Montpellier

Lille

Amiens

Nancy

Besançon

Dijon

Nice

Marseille

Paris area: 11 centers

Data collection: Who?


Data collection: How?

Clinical database

Radiological database

Biological database



Clinical database


Biological database


Clinical database

Data collection (investigators/paper CRF) Data entry (CRO: ClinInfo) Data quality control (Nîmes [Pr Daurès]) Data queries (Paris Clinical Research Unit) Database storage (Nîmes [Pr Daurès])

(questionnaires, physical examination, local imaging reading, BMD, US)



Clinical database


Biological database



Data collection (investigators / CD) Data entry (Paris Clinical Research Unit) Data storage (Paris, …)

(Pelvic X-rays, Spine X-rays, MRI)



Clinical database


Biological database


Biological database

Data collection (investigators / specific material) Data storage (Biologic Ressource Center / Bichat

Hospital [Paris])

(Serum, urines, DNA, RNA)


Study design

Data collection

Data analysis


Data analysis

Organization

Preliminary results


Data analysis

Organization

Preliminary results


Data analysis: organization

When?

How?

Who?



When?

How?

Who?


Data analysis: When?

after the last patient has completed the last visit (clinical trial)

every year for all patients (cohorts) every year for the visits for which data

are available for all patients

after the database has been locked



after the last patient has completed the last visit (clinical trial)

every year for all patients (cohorts) every year for the visits for which data

are available for all patients

after the database has been locked



M0: June 2010 M0 + M12: June 2011 M0 M24: June 2012 M0 M36: June 2013 M0 M48: June 2014 M0 M60: June 2015



When?

How?

Who?


Data analysis: How?

RFP: Request For Proposal of a research question (twice a year) Specifif format for application Scientific committee: Fautrel Bruno, Richette Pascal, Miceli-Richard Corinne,

Benessiano Joëlle, Berenbaum Francis, Breban Maxime, Claudepierre Pascal, Combe Bernard, Cotten Anne, d’Agostino Maria-Antonietta, Dargent Patricia, Daurès Jean-Pierre, Dougados Maxime, Goupille Philippe, Logeart Isabelle, Pham Thao, Roux Christian, Rudwaleit Martin, Saraux Alain, van der Heijde Désirée, Wendling Daniel

Review of the applications by the reviewers (within and outside the scientific committee)

Decision by the scientific committee If OK, the database is provided to the applicant



When?

How?

Who?


Data analysis: Who?

Embargo period: 2 years after the date a specific database has been locked

During the embargo period: Investigators Scientific committee members

After the embargo period: Any researcher


Data analysis

Organization

Preliminary results


Data analysis

Description of the database

Presentation / publication


Data analysis




- Age: n = 708 m = 33.7 SD = 8.6 Range = [18 – 60.6]

- Sex: Male n = 327 (46 %)

- B27 positive: n = 410 (57.9 %)

- Radiologic sacroiliitis: n = 182 (25.7 %)




3%

16%

9%

45%

13%

49%

21%

0%

50%

100%

periphericalarthritis

Enthesitis Dactylitis(n=92)

Chest pain Uveitis (n=60) Psoriasis(n=112)

IBD (n=21)

Percentage of patients with recent inflammatory rachialgia and past history of….

French cohort of early inflammatory back pain Baseline characteristics

ASAS criteria, Yes N = 479 ASAS criteria, No N = 211

X-Rays+MRI+

X-Rays+MRI -

X-Rays-MRI +

X-Rays-MRI -

B27+ B27-

Number 133 (28%) 49 (10%) 98 (20%) 185 (39%) 8 (4%) 203 (96%)

Age 30.2 ± 8 34.2 ± 10.8 34 ± 8.2 34 ± 8.3 29.5 ± 7.1 35.6 ± 8.4

Sex (% women) 50 (38%) 23 (47%) 41 (42%) 110 (60%) 5 (63%) 129 (64%)

Symptoms duration (months) 19 [11 – 26] 18 [9 – 29] 15 [7 – 28] 17 [10 – 27] 13 [6 – 26] 16 [9 – 24]

BASDAI 38 [24 – 57] 48 [19 – 62] 44 [30 – 58] 48 [29 – 61] 43 [30 – 49] 49 [36 – 63]

BASDAI ≥40/100 63 (47.7%) 31 (64.6%) 57 (58.2%) 112 (60.9%) 4 (50%) 138 (68%)

BASFI 20 [9 – 47] 31 [13 – 50] 25 [12 – 44] 28 [11 – 49] 18 [11 – 27] 25 [14 – 51]

BASMI 2.4 [1.8 – 3] 3 [2 – 3.5] 2 [1.6 – 3] 2 [1.6 – 3] 1.9 [1 – 2.3] 2.3 [1.8 – 3]

NSAID score (3 last months) 50 [17 – 93] 57 [36 – 112] 50 [21 – 89] 56 [30 – 100] 8,2 [0 – 30] 34 [7 – 74]

NSAIDscore (6 last months) 43 [15 – 82] 47 [20 – 95] 36 [12 – 67] 44 [20 – 79] 14 [2 – 22] 25 [5 – 55]

Uveitis+ 16 (12%) 4 (8%) 9 (9%) 15 (8%) 0 (0%) 13 (6%)

Arthritis+ 25 (19%) 15 (31%) 20 (20%) 38 (21%) 0 (0%) 43 (21%)

Enthesitis+ 47 (35%) 29 (59%) 48 (49%) 98 (53%) 0 (0%) 114 (56%)


Data analysis



Presentations during congress (1/2)

Smokers in early axial spondyloarthritis have an earlier disease onset, more inflammation and damage: results from the DESIR cohort. Oral presentation

Do HLA-B27 positive patients differ from HLA-B27 negtive patients in clinical presentation and imaging? Results from the DESIR cohort on patients with recent onset in ……… arthritis.

Poster

Psoriasis influences the phenotype of patients with early inflammatory back pain: data from the DESIR cohort. Oral presentation

Past history or present symptoms of extra-spinal manifestations are frequent in patients presenting with recent inflammatory back pain: data from the DESIR cohort.Poster

Comparison of axial spondyloarthropathy (ASPA) and non ASPA patients rheumatologist diagnosis among a recent inflammatory back pain patients cohorts – the DESIR cohort.

Oral presentation

Presentations during congress (2/2)

Impact of uveitis on the phenotype of patients with recent inflammatory back pain. Poster

Smokers in early axial spondyloarthritis have an earlier disease onset, more inflammation and damage: results from the DEvenir des Spondyloarthropathies Indifférenciées Récentes cohort. Oral presentation

Association between axial pain site and site of MRI inflammatory lesions or structural change in patietns with early inflammatory back pain. The DESIR cohort study. Oral presentation

Differences between women and men with recent onset axial spondyloarthritis: results from the DESIR cohort. Poster

Three phenotype profiles are revealed by cluster analysis in early inflammatory back pain suggestive of spondyloarthritis (SpA). Results from the Devenir des Spondyloarthropathies Indifférenciées Récentes (DESIR) cohort. Poster

Publications

1. The DESIR cohort: A 10-year follow-up of early inflammatory back pain in France: Study design and baseline characteristics of the 708 recruited patients.Dougados M, d’Agostino MA, Benessiano J, Berenbaum F, Breban M, Claudepierre P, Combe B, Dargent-Molina P, Daurès JP, Fautrel B, Feydy A, Goupille P, Leblanc V, Logeart I, Pham T, Richette P, Roux C, Rudwaleit M, Saraux A, Treluyer JM, van der Heijde D, Wendling M.Joint Bone Spine 2011 Mar 30 [Epub ahead of print]

2. HLA-B27 positive patients differ from HLA-B27 negative patietns in clinical presentation and imaging: Results from the DESIR cohort of patients with recent onsel axial spondyloarthritis.Chung HY, Machado P, vander Heijde D, Dougados M.Ann Rheum Dis 2011;in press


Conclusions

1. Potential interest of the collected data Burden of the disease Treatment effect in daily practice Physiopathology

2. YOU ARE WELCOME TO SUBMIT A RESEARCH

PROJECT!!!

www.lacohortedesir.fr

Documents

Study design Data collection Data analysis