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
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, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 22, 2014