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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:
ClinicalTrials.gov Identifier:
NCT00545454
First Posted: October 17, 2007
Last Update Posted: August 8, 2017
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.
Information provided by (Responsible Party):
Sanofi
  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 Drug: Placebos Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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)
Arms Assigned Interventions
Experimental: SSR150106 QD
90 micro grams oral solution once daily (QD)
Drug: SSR150106
Experimental: SSR150106 OEQD
90 micro grams oral solution once every other day (OEQD)
Drug: SSR150106
Placebo Comparator: Placebo
oral solution QD or OEQD
Drug: Placebos

  Eligibility

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.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT00545454


Locations
Bulgaria
Sanofi-Aventis Administrative Office
Sofia, Bulgaria
Croatia
Sanofi-Aventis Administrative Office
Zagreb, Croatia
Czechia
Sanofi-Aventis Administrative Office
Praha, Czechia
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

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00545454     History of Changes
Other Study ID Numbers: ACT5488
EudraCT 2007-00760-24
First Submitted: October 16, 2007
First Posted: October 17, 2007
Last Update Posted: August 8, 2017
Last Verified: August 2017

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