NCT00696059

Brief Summary

Studies on tumor necrosis factor alpha antagonist (anti-TNF) therapy in rheumatoid arthritis (RA) patients have found that erosive damage may "heal" in some RA patients treated with anti-TNF. Repeated examinations of adalimumab (Humira) treated RA patients, using computed tomography (CT), magnetic resonance imaging (MRI), ultrasonography (US) and radiography will allow detailed assessment of the extent of bone repair/healing during adalimumab (Humira) therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_4 rheumatoid-arthritis

Timeline
Completed

Started Aug 2004

Typical duration for phase_4 rheumatoid-arthritis

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2008

Completed
Last Updated

June 12, 2008

Status Verified

June 1, 2008

Enrollment Period

2.9 years

First QC Date

June 9, 2008

Last Update Submit

June 11, 2008

Conditions

Rheumatoid ArthritisArthritisJoint Diseases

Keywords

Rheumatoid arthritisComputed tomographyMagnetic resonance imagingRadiographyTumor necrosis factor alpha antagonists

Outcome Measures

Primary Outcomes (1)

  • By means of computed tomography and magnetic resonance imaging to investigate if repair of bone erosion occurs in rheumatoid arthritis joints during adalimumab (Humira) therapy

    52 weeks

Study Arms (1)

1

OTHER

Open-label, one arm only. All patients receiving active drug according to recommendations (adalimumab (Humira) 40 mg subcutaneously every other week).

Drug: Adalimumab (Humira)

Interventions

Adalimumab (Humira)DRUG

Adalimumab (Humira) 40 mg subcutaneously every other week

Also known as: Humira
1

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of rheumatoid arthritis according to the American College of Rheumatology 1987 criteria
  • Moderate or severely active RA, defined as a DAS28(CRP)\> 3.2
  • Moderate radiographic structural joint damage, defined as Larsen grade 2-3, in ≥ 2 wrist and/or MCP joints
  • No previous biological therapy
  • Clinical indication for biological therapy, according to the treating physician
  • No history of tuberculosis, and no signs of tuberculosis at chest radiograph or Mantoux test.
  • No contra-indications for TNF-alpha antagonist treatment
  • Co-operability of the patient, including that the patient is willing and able to comply with the treatment and scheduled follow-up visits and examinations
  • Oral and signed informed consent by the patient

You may not qualify if:

  • Acute infection, and known chronic viral infection such as HIV or hepatitis B and C
  • Oral treatment with prednisolone \>10 mg per day
  • Malignant lymphoma and other malignant disease
  • Other serious concomitant diseases (uncontrolled/severe kidney, liver, haematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological or cerebral disease (including demyelinating disease))
  • Pregnancy and lactation. Patients must use safe anti-conception during the treatment.
  • Development of SLE-like disease. Occurrence of positive ANA and/or anti-DNA antibodies without clinical symptoms is not considered a contra-indication.
  • Contra-indications for MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Department of Rheumatology, Copenhagen University Hospital, Rigshospitalet

Copenhagen, DK-2100, Denmark

Location

Department of Rheumatology, Bispebjerg University Hospital

Copenhagen, DK-2400, Denmark

Location

Department of Rheumatology, Gentofte University Hospital

Hellerup, DK-2900, Denmark

Location

Department of Rheumatology, Herlev University Hospital

Herlev, DK-2630, Denmark

Location

Department of Rheumatology, Hvidovre University Hospital

Hvidovre, DK-2650, Denmark

Location

Related Publications (1)

  • Krabbe S, Bolce R, Brahe CH, Dohn UM, Ejbjerg BJ, Hetland ML, Sasso EH, Chernoff D, Hansen MS, Knudsen LS, Hansen A, Madsen OR, Hasselquist M, Moller J, Ostergaard M. Investigation of a multi-biomarker disease activity score in rheumatoid arthritis by comparison with magnetic resonance imaging, computed tomography, ultrasonography, and radiography parameters of inflammation and damage. Scand J Rheumatol. 2017 Sep;46(5):353-358. doi: 10.1080/03009742.2016.1211315. Epub 2016 Sep 28.

    PMID: 27682742DERIVED

MeSH Terms

Conditions

Arthritis, RheumatoidArthritisJoint Diseases

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Mikkel Østergaard, Professor

    Department of Rheumatology, Hvidovre University Hospital

    PRINCIPAL INVESTIGATOR

  • Uffe Møller Døhn, M.D

    Department of Rheumatology, Hvidovre University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 9, 2008

First Posted

June 12, 2008

Study Start

August 1, 2004

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

June 12, 2008

Record last verified: 2008-06

Locations

DK(5)