Comparison of Adalimumab and Infliximab Treatment of Rheumatoid Arthritis

NCT ID: NCT00216177

Last Updated: 2009-08-18

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2009-06-30

Brief Summary

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

The purpose of this study is to establish whether RA patients with moderate to severe disease activity with unsustainable response to infliximab 3 mg/kg every 8 weeks have better efficacy with adalimumab 40 mg s.c. eow compared to infliximab 3 mg/kg i.v. every 6 weeks.

Detailed Description

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

Conditions

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

Rheumatoid Arthritis

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

NONE

Interventions

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

Adalimumab

Humira

Intervention Type DRUG

Infliximab

Remicade

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

remicade Humira

Eligibility Criteria

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

Inclusion Criteria

* ACR criteria fulfilled,DAS28-3(CRP \> 3.2
* \> 6 months prior treatment with infliximab 3 mg/kg i.v. every 8 week with initial response
* Fading clinical response to infliximab
* Negative pregnancy test (women with childbearing potential)
* Use of reliable method of contraception (women with childbearing potential)
* Informed consent

Exclusion Criteria

* Age less than 18 years
* Lack of co-operability
* Positive serology for hepatitis B or C
* History of positive HIV status
* History of TB or untreated latent TB
* Histoplasmosis or Listeriosis
* Pregnancy or breastfeeding
* Persistent or recurrent infections
* History of cancer
* Uncontrolled diabetes
* Ischaemic heart disease
* Congestive heart failure (NYHA 3-4)
* Active inflammatory bowel disease
* Recent stroke (within 3 months)
* History of or current inflammatory joint disease other than RA
* Previous diagnosis or signs of central nervous system demyelinating disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role collaborator

Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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

Hvidovre Hospital

Principal Investigators

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

Henrik Skjodt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital

Locations

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

Hvidovre Hospital

Copenhagen, , Denmark

Site Status RECRUITING

Bispebjerg Hospital

Copenhagen, , Denmark

Site Status RECRUITING

Gentofte Amtssygehus

Copenhagen, , Denmark

Site Status RECRUITING

Glostrup Hospital

Copenhagen, , Denmark

Site Status RECRUITING

Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Graasten Gigthospital

Gråsten, , Denmark

Site Status RECRUITING

Countries

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

Denmark

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Henrik Skjodt, MD, PhD

Role: CONTACT

3632 3311

Mikkel Ostergaard, MD, DMedSci

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Henrik Skjodt, MD, PhD

Role: primary

Mikkel Ostergaard, MD, DMedSci

Role: backup

Karsten, Asmussen

Role: primary

Ole Rintek, MD, DMedSci

Role: primary

Gorm Thamsborg, MD, DMedSci

Role: primary

Bo Baslund, MD, PhD

Role: primary

Annette Hansen, MD, PhD

Role: backup

Lis S Andersen, MD, PhD

Role: primary

Other Identifiers

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

EudraCT no: 2005-001633-14

Identifier Type: -

Identifier Source: secondary_id

Switch/HUM 05-001

Identifier Type: -

Identifier Source: secondary_id

232-003

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.