An MRI-guided Treatment Strategy to Prevent Disease Progression in Patients With Rheumatoid Arthritis

NCT01656278 | Completed DMC

• 1 other identifier: IMAGINE-RA
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this study is to examine whether an magnetic resonance imaging (MRI) -guided treatment strategy based on a predefined treatment algorithm can prevent progression of erosive joint damage, increase remission rate and improve functional level in the short and long term in patients with rheumatoid arthritis (RA).

Conditions

Arthritis; Arthritis, Rheumatoid; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases

Keywords

Arthritis, Rheumatoid/drug therapy; Arthritis, Rheumatoid/pathology; Disease Progression; Longitudinal Studies; Prospective Studies; Imaging, Magnetic Resonance; Remission Induction; Synovitis/immunology; Synovitis/pathology; Wrist Joint/pathology; Wrist Joint/physiopathology

Outcome Measures

Primary Outcomes (2)

• DAS28 remission (<2.6)

  24 month

• No radiographic progression (assessed by the Sharp/vdHeijde method).

  24 month

Secondary Outcomes (11)

• No radiographic progression (Sharp/vdHeijde score).

  24 month

• No MRI erosion (RAMRIS) score

  24 month

• MRI synovitis (RAMRIS) score

  24 months

• MRI bone marrow oedema (RAMRIS) score

  24 months

• HAQ score

  24 month

Other Outcomes (1)

• Dynamic MRI

  24 month

Study Arms (2)

Conventional biochemical and clinical examinations

ACTIVE COMPARATOR

Biochemical and clinical examinations

Other: Conventional biochemical and clinical examinations

Conventional biochemical and clinical examinations and MRI.

EXPERIMENTAL

Biochemical and clinical examinations and MRI.

Procedure: Magnetic resonance imaging (MRI)

Interventions

Magnetic resonance imaging (MRI) PROCEDURE

Treatment algorithm based on conventional biochemical/clinical examinations AND MRI of unilateral 2nd to 5th MCP joints and wrist on dominant side. Assessed month 0, 4, 8, 12, 16, 20, 24 with treatment intensification after predefined treatment algorithm in the case of "unsatisfactory inflammatory activity", which is defined as the presence of at least one physically swollen joint and DAS28\>3.2 AND/OR MRI-detected bone marrow oedema score \> 0 (RAMRIS-score)

Conventional biochemical and clinical examinations and MRI.

Conventional biochemical and clinical examinations OTHER

Treatment algorithm based on conventional biochemical and clinical examinations. Assessed month 0, 4, 8, 12, 16, 20, 24 with treatment intensification after predefined treatment algorithm in the case of "unsatisfactory inflammatory activity", which is defined as the presence of at least one clinically swollen joint and DAS28\>3.2

Conventional biochemical and clinical examinations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• RA according to ACR (American College of Rheumatology)/EULAR (European League Against Rheumatism) 2010 criteria.
• Anti-CCP positivity
• Erosions on conventional X-ray of hands, wrists and/or feet
• No clinically swollen joints
• DAS28 (4 variable, CRP) \< 3.2
• Unchanged anti-rheumatic treatment in the previous 6 weeks or more
• No previous treatment with biological medication
• No contra-indications for TNF-alpha-inhibiting treatment
• No contra-indications for MRI
• s-creatinine within normal range
• Ability and willingness to give written and oral informed consent and fulfil the requirements of the study programme with reference to the protocol

You may not qualify if:

• Previous or current biological treatment
• Known intolerance to methotrexate treatment which means that the patient is not able to tolerate a minimum of MTX 7.5 mg (minimum dose).
• Oral glucocorticoid administration \> 5 mg/day
• Myocrisin treatment
• Affected liver enzymes \> 2 x the upper limit of normal at the time of screening
• Current and/or imminent wish to become pregnant
• Contra-indications for TNF-alpha-inhibiting treatment
• Contra-indications for MRI
• Known alcohol/drug abuse
• Inability to give informed consent
• Inability to cooperate with the study programme due to physical or mental reasons

Sponsors & Collaborators

• Professor of Rheumatology, MD, DMSci, Kim Horslev-Petersen: lead
• King Christian X´Hospital for Rheumatic Diseases: collaborator
• Slagelse Hospital: collaborator
• Glostrup University Hospital, Copenhagen: collaborator
• Abbott: collaborator

Study Sites (9)

Dep. of Rheumatology Aarhus Hospital

Aarhus, 8600, Denmark

Location

Dep. of Rheumatology Frederiksberg Hospital

Copenhagen, 2000, Denmark

Location

Dep. of Rheumatology Glostrup Hospital

Copenhagen, 2600, Denmark

Location

Dep. of Rheumatology Gentofte Hospital

Copenhagen, 2900, Denmark

Location

Dep. of Rheumatology King Christian X´Hospital for Rheumatic Diseases

Gråsten, 6300, Denmark

Location

Department of Rheumatology University Hospital Vendsyssel

Hjørring, DK-9800, Denmark

Location

Dep. of rheumatology Odense Hospital

Odense, 5000, Denmark

Location

Dep. of Rheumatology Silkeborg Hospital

Silkeborg, 8600, Denmark

Location

Dep. of Rheumatology Slagelse Hospital

Slagelse, 4200, Denmark

Location

Related Publications (4)

• Moller-Bisgaard S, Horslev-Petersen K, Ejbjerg B, Hetland ML, Christensen R, Ornbjerg LM, Glinatsi D, Moller JM, Boesen M, Stengaard-Pedersen K, Madsen OR, Jensen B, Villadsen JA, Hauge EM, Bennett P, Hendricks O, Asmussen K, Kowalski M, Lindegaard H, Bliddal H, Krogh NS, Ellingsen T, Nielsen AH, Larsen L, Jurik AG, Thomsen HS, Ostergaard M. Effect of initiating biologics compared to intensifying conventional DMARDs on clinical and MRI outcomes in established rheumatoid arthritis patients in clinical remission: Secondary analyses of the IMAGINE-RA trial. Scand J Rheumatol. 2022 Jul;51(4):268-278. doi: 10.1080/03009742.2021.1935312. Epub 2021 Sep 2.

  PMID: 34474649 DERIVED

• Moller-Bisgaard S, Georgiadis S, Horslev-Petersen K, Ejbjerg B, Hetland ML, Ornbjerg LM, Glinatsi D, Moller J, Boesen M, Stengaard-Pedersen K, Madsen OR, Jensen B, Villadsen JA, Hauge EM, Bennett P, Hendricks O, Asmussen K, Kowalski M, Lindegaard H, Bliddal H, Krogh NS, Ellingsen T, Nielsen AH, Balding L, Jurik AG, Thomsen HS, Ostergaard M. Predictors of joint damage progression and stringent remission in patients with established rheumatoid arthritis in clinical remission. Rheumatology (Oxford). 2021 Jan 5;60(1):380-391. doi: 10.1093/rheumatology/keaa496.

  PMID: 32929463 DERIVED

• Moller-Bisgaard S, Horslev-Petersen K, Ejbjerg B, Hetland ML, Ornbjerg LM, Glinatsi D, Moller J, Boesen M, Christensen R, Stengaard-Pedersen K, Madsen OR, Jensen B, Villadsen JA, Hauge EM, Bennett P, Hendricks O, Asmussen K, Kowalski M, Lindegaard H, Nielsen SM, Bliddal H, Krogh NS, Ellingsen T, Nielsen AH, Balding L, Jurik AG, Thomsen HS, Ostergaard M. Effect of Magnetic Resonance Imaging vs Conventional Treat-to-Target Strategies on Disease Activity Remission and Radiographic Progression in Rheumatoid Arthritis: The IMAGINE-RA Randomized Clinical Trial. JAMA. 2019 Feb 5;321(5):461-472. doi: 10.1001/jama.2018.21362.

  PMID: 30721294 DERIVED

• Moller-Bisgaard S, Horslev-Petersen K, Ejbjerg BJ, Boesen M, Hetland ML, Christensen R, Moller J, Krogh NS, Stengaard-Pedersen K, Ostergaard M. Impact of a magnetic resonance imaging-guided treat-to-target strategy on disease activity and progression in patients with rheumatoid arthritis (the IMAGINE-RA trial): study protocol for a randomized controlled trial. Trials. 2015 Apr 21;16:178. doi: 10.1186/s13063-015-0693-2.

  PMID: 25896862 DERIVED

MeSH Terms

Conditions

Arthritis; Arthritis, Rheumatoid; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Disease Progression; Synovitis

Interventions

Magnetic Resonance Spectroscopy; Restraint, Physical

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Behavior Control; Therapeutics; Immobilization

Study Officials

• Kim Hørslev-Petersen, Professor

  King Christian X´Hospital for Rheumatic Diseases

  PRINCIPAL INVESTIGATOR

• Signe Møller-Bisgaard, MD

  Dep. of Rheumatology, Rigshospitalet, Glostrup

  STUDY DIRECTOR

• Mikkel Østergaard, Professor

  Dep. of Rheumatology, Rigshospitalet, Glostrup

  STUDY CHAIR

• Bo Ejbjerg, MD, PhD

  Dep. of Rheumatology Slagelse Hospital

  STUDY CHAIR

• Merete Hetland, MD, PhD, DMSci

  Dep. of Rheumatology, Rigshospitalet, Glostrup

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Rheumatology, MD, DMSci

Study Record Dates

• First Submitted: July 5, 2012
• First Posted: August 2, 2012
• Study Start: March 1, 2012
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: June 23, 2017

Record last verified: 2017-06

Locations

DK (9)