Spacing of TNF-Blocker Injections in Rheumatoid Arthritis Study - Full Text View

Sponsors and Collaborators:	Assistance Publique - Hôpitaux de Paris French Society of Rheumatology
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00780793

Purpose

Remission is nowadays the recommended therapeutic objective in rheumatoid arthritis. Once this objective is achieved thanks to TNF-blockers, the optimal therapeutic strategy remains unclear, either therapeutic maintenance or progressive DMARD tapering (with a non quantified risk of disease flare).

STRASS is a 2-arm randomized controlled trial aiming to compare these 2 strategies (DMARD maintenance or progressive spacing of TNF-blocker injections) in terms of remission maintenance, relapse risk, safety issues and economic consequences during 18 months.

The inclusion period is 18 months, between September 2008 and February 2010.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: progressive spacing of TNF-blocker injections Drug: DMARD maintenance	Phase IV

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Adalimumab Etanercept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effect of TNF-Blocker Injections Spacing on Rheumatoid Arthritis Inflammatory Activity in Patients in Clinical Remission or Low Disease Activity

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

RA inflammatory activity over 18 months based on repeated DAS28 measures [ Time Frame: over 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

RA inflammatory activity over 18 months estimated by DAS44 repeated measures [ Time Frame: over 18 months ] [ Designated as safety issue: No ]
Cost - Effectiveness ratio calculated as: (CostMaintenance - CostSpacing) / (EfficacyMaintenance - EfficacySpacing); [ Time Frame: during the study ] [ Designated as safety issue: No ]
Relapse rate over 18 months based on Kaplan Meier survival analysis [ Time Frame: over 18 months ] [ Designated as safety issue: No ]
Functional impairment based on HAQ index [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
Health-related quality of life on SF-36 [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
Utility based on EQ-5D instrument [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
Structural damage progression over 18 months assessed with the van der HEIJDE-modified Sharp score (SHS) [ Time Frame: over 18 months ] [ Designated as safety issue: Yes ]
Determinants of maintained remission or relapse after TNF-blocker injection spacing [ Time Frame: during teh study ] [ Designated as safety issue: No ]

Estimated Enrollment:	250
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1-M : Maintenance: Active Comparator Usual care	Drug: DMARD maintenance DMARD maintenance
2 -S : Spacing of TNF-blocker injections: Experimental Spacing of TNF-blocker injections	Drug: progressive spacing of TNF-blocker injections Experimental arm Progressive spacing of TNF-blocker injections according to the following algorithm : if DAS28 ≤ 2.6 at trimestrial assessment: go for step N+1 if DAS28 > 2.6 and DAS28 change ≤ 0.6: continue at step N if DAS28 > 2.6 and DAS28 change > 0.6 : return to step N-1 (relapse as defined by the European expert consensus). Step 0 (inclusion) : Adalimumab 40 mg / 14 days Etanercept 50 mg / 7 days Step 1 : Adalimumab 40 mg / 21 days Etanercept 50 mg / 10 days Step 2 : Adalimumab 40 mg / 28 days Etanercept 50 mg / 14 days Step 3 : Adalimumab 40 mg / 42 days Etanercept 50 mg / 21 days Step 4 : TNF-blocker stop

Arms

Assigned Interventions

1-M : Maintenance: Active Comparator

Usual care

Drug: DMARD maintenance

DMARD maintenance

2 -S : Spacing of TNF-blocker injections: Experimental

Spacing of TNF-blocker injections

Drug: progressive spacing of TNF-blocker injections

Experimental arm

Progressive spacing of TNF-blocker injections according to the following algorithm :

if DAS28 ≤ 2.6 at trimestrial assessment: go for step N+1
if DAS28 > 2.6 and DAS28 change ≤ 0.6: continue at step N
if DAS28 > 2.6 and DAS28 change > 0.6 : return to step N-1 (relapse as defined by the European expert consensus).

Step 0 (inclusion) :

Adalimumab 40 mg / 14 days
Etanercept 50 mg / 7 days

Step 1 :

Adalimumab 40 mg / 21 days
Etanercept 50 mg / 10 days

Step 2 :

Adalimumab 40 mg / 28 days
Etanercept 50 mg / 14 days

Step 3 :

Adalimumab 40 mg / 42 days
Etanercept 50 mg / 21 days

Step 4 :

TNF-blocker stop

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients aged 18 or more, diagnosed with RA according to the 1987 ACR classification criteria;
RA treated with subcutaneous TNF-blockers (étanercept or adalimumab) at stable and standard dosage for 1 year or more, as monotherapy or associated with stable conventional DMARD;
RA in clinical remission, defined as a stable DAS28 ≤ 2.6 for 6 months or more, without any structural damage progression on X-rays (local reading by the treating rheumatologist);

Exclusion Criteria:

Treatment with steroids;
progressing disease on X-rays during the year preceding the trial;
surgery planed in the 18 coming months;
pregnancy;
on-going neoplastic disease;
other auto-immune disorders different from RA;
inability to speak or understand French;
absence of signed informed consent;
absence of medical insurance coverage.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00780793

Contacts

Contact: Bruno Fautrel, MD, PhD

+331.42.17.76.20 / 21

bruno.fautrel@psl.aphp.fr

Locations

France
Service de rhumatologie / Groupe hospitalier Pitié Salpêtrière	Recruiting
Paris, France, 75013
Contact: Bruno Fautrel, MD, PhD bruno.fautrel@psl.aphp.fr

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

French Society of Rheumatology

Investigators

Principal Investigator:

Bruno Fautrel, MD, PhD

Assistance Publique - Hôpitaux de Paris

More Information

Responsible Party:	Department Clinical Research of Developpement ( Aurélie GUIMFACK )
Study ID Numbers:	AOM 07127
Study First Received:	October 27, 2008
Last Updated:	October 31, 2008
ClinicalTrials.gov Identifier:	NCT00780793
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Rheumatoid arthritis
Remission
Therapeutic strategy
DMARDs
Biological agents

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Adalimumab

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009