Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 15 of 39 for:    "Spinal Disease" | "Benzocaine"

Effect of Spacing of Anti-TNF Drugs in Ankylosing Spondylitis With Low Disease Activity (SPACING)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01610947
Recruitment Status : Completed
First Posted : June 4, 2012
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:
Patients with spondyloarthritis, already treated by TNF blocker (adalimumab, etanercept or infliximab), and in stable low disease activity for at least 6 months, will be randomized into 2 groups: either keeping on their usual treatment with stable doses or progressive spacing of injections of their treatment. Follow-up will be done every 3 months during 12 months, with regular monitoring of disease activity and, in patients from the group "spacing", modification of the rhythm of injections according to health state and predefined protocol.

Condition or disease Intervention/treatment Phase
Spondyloarthritis Drug: Adalimumab, Etanercept, Golimumab or infliximab Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 398 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Spacing of Anti-TNF Drugs in Ankylosing Spondylitis With Low Disease Activity: a Randomized Controlled Trial
Actual Study Start Date : May 14, 2012
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 2018


Arm Intervention/treatment
Active Comparator: Maintain
Continuation of usual treatment with fixed intervals according to standard recommendations
Drug: Adalimumab, Etanercept, Golimumab or infliximab
Continuation of usual treatment with fixed intervals according to standard recommendations

Active Comparator: Spacing
Progressive spacing of injections according to disease activity observed during follow-up and predefined protocol.
Drug: Adalimumab, Etanercept, Golimumab or infliximab
Progressive spacing of injections according to disease activity observed during follow-up and predefined protocol




Primary Outcome Measures :
  1. Proportion of patients remaining in low disease activity [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Medico-economic comparison of arms [ Time Frame: 12 months ]
    The cost-efficacy ratio will be compared between the 2 arms (maintain and spacing). The objective is to see if the spacing of the treatments will allow a better tolerance and reduce the cost due to the treatments.To assess this cost-efficacy ratio, questionnaires will be used (quality of life SF36, medico-economic Euroqol).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients with spondyloarthritis according to ASAS criteria
  • Stable low disease activity for at least 6 months
  • Already treated by TNF blocking drug (adalimumab, etanercept or infliximab)

Exclusion Criteria:

  • Raised acute phase reactants
  • participation in another clinical trial
  • Structural progression of peripheral joint damage
  • Scheduled surgery within 12 months
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01610947


Locations
Layout table for location information
France
Lapeyronie Hospital
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier

Layout table for additonal information
Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01610947     History of Changes
Other Study ID Numbers: 8785
First Posted: June 4, 2012    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019
Keywords provided by University Hospital, Montpellier:
Spondyloarthritis
Anti-TNF
Adalimumab
Etanercept
Infliximab
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Diseases
Spondylitis
Spondylitis, Ankylosing
Spondylarthritis
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spondylarthropathies
Ankylosis
Joint Diseases
Arthritis
Adalimumab
Etanercept
Infliximab
Antibodies, Monoclonal
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors