Adalimumab in Rheumatoid Arthritis. An Investigation of Wholebody MRI, Conventional MRI, CT and Circulating Biomarkers

NCT01029613 | Completed DMC

• 1 other identifier: WRAP
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 8

Brief Summary

Adalimumab in rheumatoid arthritis. An investigation of changes in disease activity and course of joint destruction by use of 3 Tesla Whole-Body MRI, dedicated 3 Tesla MRI and CT of the hand, and soluble biomarkers. Furthermore to compare ultrasound examination with wholebody MRI etc.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• EULAR response criteria

  16 weeks

Secondary Outcomes (3)

• Number of joints with inflammation on MRI

  16 and 52 weeks

• Erosions on X-rays and CT

  52 weeks

• Biomarkers

  16 and 52 weeks

Study Arms (1)

Rheumatoid arthritis

Drug: Adalimumab

Interventions

Adalimumab DRUG

sc. inj. Humira 40 mg every other week from week 0 to 52

Rheumatoid arthritis

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with rheumatoid arthritis according to the ACR criteria (1987) with high disease activity starting TNF-alpha inhibitor

You may qualify if:

• Age \> 18 years old and \< 85 years old
• RA in accordance with American College of Rheumatology 1987 criteria
• Moderate or highly active RA defined as DAS28 \> 3,2 (CRP based)
• Clinical indication for TNF-α inhibitor treatment by the treating physician
• No contraindications for TNF-α inhibitor treatment
• No contraindications for MRI
• Serum creatinine in normal range
• Sufficient contraception for fertile women
• Capable of giving informed consent
• Capable of complying with the examination program of the protocol

You may not qualify if:

• Pregnancy wish, pregnancy or breast-feeding
• Contraindications for TNF-α inhibitor treatment
• Contraindications for MRI
• Known recent drug or alcohol abuse
• Failure to provide written consent
• Incapable of complying with the examination program for physical or mental reasons

Sponsors & Collaborators

• Glostrup University Hospital, Copenhagen: lead

Study Sites (8)

Dep. of medicine, Herlev Hospital

Copenhagen, Denmark

Location

Dep. of Radiology, Herlev Hospital

Copenhagen, Denmark

Location

Dep. of Rheumatology, Frederiksberg and Bispebjerg Hospitals

Copenhagen, Denmark

Location

Dep. of Rheumatology, Gentofte Hospital

Copenhagen, Denmark

Location

Dep. of Rheumatology, Glostrup Hospital

Copenhagen, Denmark

Location

Dep. of Rheumatologym Glostrup Hospital

Copenhagen, Denmark

Location

Dep. of Rheumatology, Helsingør Hospital

Hørsholm, Denmark

Location

Dep. of Rheumatology, Køge Hospital

Køge, Denmark

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Mikkel Østergaard, Professor

  Dep. of Rheumatology, Glostrup Hospital

  PRINCIPAL INVESTIGATOR

• Susanne J Pedersen, MD

  Dep. of Rheumatology, Glostrup Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2009
• First Posted: December 10, 2009
• Study Start: December 1, 2009
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 19, 2015

Record last verified: 2015-08

Locations

DK (8)