Activity and Safety of Oral Administration of SSR150106XB for the Reduction of Inflammation in Patients With Active Rheumatoid Arthritis (ACCORD-RA)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00545454
First received: October 16, 2007
Last updated: January 15, 2009
Last verified: January 2009
  Purpose

The primary objective of this study is to assess the reduction of systemic inflammation as measured by serum levels of C-reactive protein (CRP).

The secondary objectives are:

  • to assess the reduction of systemic inflammation as measured changes in acute phase protein, serum amyloid A (SAA) and cytokine interleukin-6 (IL-6), and clinical American College of Rheumatology response rate, and morning stiffness duration;
  • to assess the effect on pain relief within first 14 days;
  • to obtain evidence of the safety and tolerability of SSR150106;
  • to document trough plasma levels of SSR150106 and its first metabolite.

Condition Intervention Phase
Rheumatoid Arthritis
Drug: SSR150106
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Activity and Safety of Oral Administration of SSR150106XB for the Reduction of Inflammation in Patients With Active Rheumatoid Arthritis (RA): A 4-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel Group Study of 90 µg Administered Once Daily and 90 µg Once Every Other Day

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change from baseline in mean C-Reactive Protein level [ Time Frame: end of the 4-week double-blind treatment period ]

Secondary Outcome Measures:
  • C-Reactive Protein, Serum Amyloid A and Cytokine Interleukin-6 levels [ Time Frame: at all time points measured ]
  • Improvement responder rates based on the American College of Rheumatology criteria [ Time Frame: at all time points measured ]
  • Pain relief (change from baseline) [ Time Frame: until day 14 ]
  • Safety and tolerability [ Time Frame: During the entire study patient's participation ]
  • Plasma levels of SSR150106 and its first metabolite [ Time Frame: On a weekly basis during treatment phase, except at the end of the 3rd week ]

Enrollment: 79
Study Start Date: October 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Either treatment-naïve patients, or those who have discontinued their Rheumatoid Arthritis-directed medication due to intolerability or insufficient efficacy
  • At least 9 out of 68 tender joints; 6 out of 66 swollen joints; morning stiffness 45 min
  • C-Reactive Protein >=1.8 mg/dl confirmed during screening period
  • Non-poor Cytochrome P2D6 metabolizer status

Exclusion Criteria:

  • Functional Rheumatoid Arthritis class IV
  • Fever
  • Infections with hepatitis B, or C, or HIV
  • Presence or history (<5 years) of cancer
  • Manifest or latent tuberculosis
  • Functional abnormalities (including laboratory values) judged as clinically relevant

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545454

Locations
Bulgaria
Sanofi-Aventis Administrative Office
Sofia, Bulgaria
Croatia
Sanofi-Aventis Administrative Office
Zagreb, Croatia
Czech Republic
Sanofi-Aventis Administrative Office
Praha, Czech Republic
Romania
Sanofi-Aventis Administrative Office
Bucuresti, Romania
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Slovakia
Sanofi-Aventis Administrative Office
Bratislava, Slovakia
Ukraine
Sanofi-Aventis Administrative Office
Kiev, Ukraine
Sponsors and Collaborators
Sanofi
Investigators
Principal Investigator: Karel PAVELKA, Prof., MD Karel PAVELKA
  More Information

Additional Information:
No publications provided

Responsible Party: ICD, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00545454     History of Changes
Other Study ID Numbers: ACT5488, EudraCT 2007-00760-24
Study First Received: October 16, 2007
Last Updated: January 15, 2009
Health Authority: Czech Republic: State Institute for Drug Control
Slovakia: State Institute for Drug Control
Romania: State Institute for Drug Control

Keywords provided by Sanofi:
Inflammation
anti-cytokine
anti-chemokine

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Inflammation
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014