CClinicalTrials.gg
Status unknownNCT01292616Updated Feb 24, 2012

Effect of TNF-Inhibition Combined With Conventional DMARDs on Cervical Pannus in Patients With RA and Cervical Spine Involvement

An observational study in Rheumatoid Arthritis, sponsored by University of Zurich. Status unknown at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-02-24.

Sponsored by University of Zurich · Observational

The sponsor has not verified this record recently (last verified Feb 2012), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
15
Ages
18 Years and older
Sex
All
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Study summary

Atlantoaxial subluxation (AAS) is a complication of rheumatoid arthritis (RA) due to pannus formation around the odontoid process of C2 of the cervical spine. It occurs frequently in 15-30% of all RA patients. AAS may occur relatively early in the course of disease within the first years. The diagnosis of AAS identifies a patient population with a poor outcome. There is evidence that combination treatment with disease-modifying anti-rheumatic drugs (DMARD) may retard the development of AAS. However, it is not known whether treatment with inhibitors of tumor necrosis factor alpha (TNF) may lead to regression of cervical pannus and prevention or reduction of AAS.

Clinical studies analysing the effectiveness of TNF-inhibitors combined with conventional DMARD therapy, in the treatment of cervical spine involvement leading to AAS, are needed. This proposal for a pilot study aims at assessing the feasibility of an MRI-based measurement of pannus volume in patients before and after treatment with a TNF-inhibitor.

Primary objective: To show that measurements of pannus mass with MRI is feasible. Secondary objective: To assess whether pannus mass decreases measurably in patients treated with TNF-inhibitors.

This pilot study is prospective, non-randomized. The choice of therapy at any time during the study is entirely up to the treating rheumatologist.

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Conditions studied

  • Rheumatoid Arthritis
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In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's planned enrollment of 15 is below the median of 155 across 1,057 observational studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients with rheumatoid arthritis (RA) that have cervical involvement documented with MRI showing pannus in the atlanto-axial joint.

Inclusion criteria

  • RA fulfilling the criteria of the american college of rheumatology (ACR) (revised 1987)
  • 18 years and older
  • Cervical pain
  • Recent MRI with detectable atlanto-axial pannus

Exclusion criteria

Exclusion criteria:

  • Use of TNF-inhibitors 3 months prior to inclusion
  • Previous treatment with any biologics other than TNF-Blockers
  • History of inflammatory joint disease other than RA
  • History of active tuberculosis, histoplasmosis or listeriosis
  • History of lymphoma or other malignancies within 5 years
  • Contraindication for the use of TNF inhibitors
  • Comorbidities: severe myocardial dysfunction, recent stroke (within 3 months), uncontrolled diabetes and other disease which in the opinion of the investigator, would put the subject at risk by participation in the trial
  • History of demyelinating disorders
  • Persistent or recurrent infections
  • Pregnancy or breast feeding
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
15 participants (estimated)

Interventions

  • Drugtherapy with disease-modifying anti rheumatic drugs (DMARD)

    DMARD drug and dosage is chosen by the treating physician without restriction by the study

06

Study locations

1 of 1 sites recruiting
  • University Hospital Zurich, Division of Rheumatology
    Zurich, ZH 8091, Switzerland
    Recruiting
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01292616
Lead sponsor
University of Zurich
Responsible party
Sponsor
First posted
Feb 9, 2011
Start date
Oct 2011
Completion
Oct 2012 (estimated)
Last update
Feb 24, 2012

Study contacts

Diego Kyburz, Prof. MD
Contact
diego.kyburz@usz.ch
+41 (0)44 255 11 11
Diego Kyburz, Prof. MD
principal investigator · University Hospital Zurich, Division of Rheumatology
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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