Comparison of Adalimumab and Infliximab Treatment of Rheumatoid Arthritis

Randomised, Multicenter, Open-label, Parallel-group Study Comparing Adalimumab 40 mg s.c. Eow Versus Infliximab 3 mg/kg i.v. Every 6 Weeks in Rheumatoid Arthritis Patients With Unsustainable Clinical Response to Infliximab 3 mg/kg Every 8 Weeks

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00216177

Enrollment

112

Registered

2005-09-22

Start date

2005-09-30

Completion date

2009-06-30

Last updated

2009-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief summary

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.

Interventions

DRUGInfliximab

Remicade

DRUGAdalimumab

Humira

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Proportion of patients achieving combined good or moderate EULAR responses at week 24	six months

Secondary

Measure	Time frame
ACR20/50/70 response at week 2, 6, 12, 18 and 24	six months

Countries

Denmark

Contacts

Primary ContactHenrik Skjodt, MD, PhD

hskj@dadlnet.dk3632 3311

Backup ContactMikkel Ostergaard, MD, DMedSci

mo@dadlnet.dk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026