MedDataX Logo

HECTHOR: Humira to Spare Steroids in Giant Cell Arteritis

NCT ID: NCT00305539

Last Updated: 2012-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2011-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Hypothesis: In giant cell arteritis (GCA), a short initial treatment with anti-TNF may allow a faster decrease of steroids dosage and therefore avoid some of the adverse events of steroids.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The protocol consists of a SC injection of adalimumab or placebo every 2 weeks for 10 weeks added to steroids

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Giant Cell Arteritis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Giant Cell Arteritis Placebo Anti-TNF Multicenter-randomized-trial Proved GCA according to ACR criteria (HUNDER et al 1990)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type ACTIVE_COMPARATOR

adalimumab

Intervention Type DRUG

40 mg sc / for 3 months

2

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

adalimumab

40 mg sc / for 3 months

Intervention Type DRUG

placebo

placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age ≥ 50 years
* ACR criteria for Giant cell arteritis (HUNDER 1990)
* Positive Temporal artery biopsy

Exclusion Criteria

* Prednisone treatment for a different disease at a dose \>15 mg/day
* Corticoid treatment for GCA more than 10 days
* GCA treatment with prednisone \> 1 mg/kg whatever period of time
* GCA treatment with an anti-TNF, MTX, cyclosporine, cyclophosphamide, dapsone or steroid bolus
* Recent, permanent or transient visual loss due to GCA and the presence of any specific visual abnormality (diplopia, hallucination)
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Abbott

INDUSTRY

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Xavier Mariette, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Bicêtre, APHP, France

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hôpital Bicêtre

Le Kremlin-Bicêtre, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Seror R, Baron G, Hachulla E, Debandt M, Larroche C, Puechal X, Maurier F, de Wazieres B, Quemeneur T, Ravaud P, Mariette X. Adalimumab for steroid sparing in patients with giant-cell arteritis: results of a multicentre randomised controlled trial. Ann Rheum Dis. 2014 Dec;73(12):2074-81. doi: 10.1136/annrheumdis-2013-203586. Epub 2013 Jul 29.

Reference Type DERIVED
PMID: 23897775 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P041203

Identifier Type: -

Identifier Source: org_study_id