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N/A N=34 Randomized Triple-blind Basic Science

Inflammation and Insulin Resistance in Rheumatoid Arthritis

Rheumatoid Arthritis

Bottom Line

View on ClinicalTrials.gov: NCT00763139 ↗
Enrolled (actual)
34
Serious AEs
2.9%
Results posted
Nov 2014
Primary outcome: Primary: Disease Activity Score Based on 28-joint Disease Activity Score (DAS28) — 4.40; 4.03; 4.57; 4.48 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Pioglitazone (Drug); Placebo (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Vanderbilt University
Primary completion
Sep 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Disease Activity Score Based on 28-joint Disease Activity Score (DAS28)		 4.40; 4.03; 4.57; 4.48 —
PRIMARY
Homeostasis Model Assessment (HOMA) for Insulin Sensitivity		 2.83; 2.44; 2.38; 3.11 —
SECONDARY
C-reactive Protein (CRP)		 8.1; 5.02; 7.7; 8.25 —
SECONDARY
ESR		 18.5; 17; 19.5; 18.88 —

Summary

Rheumatoid arthritis (RA) is a form of arthritis that causes pain, swelling, stiffness, and loss of function in the joints. Over time, joint deformity, joint destruction, and loss of function can occur. Current treatment aims to improve symptoms, but there is no cure for the disease. Pioglitazone is drug that is effective in treating people with diabetes. This study will determine whether pioglitazone can also be used to effectively treat people with RA.

Eligibility Criteria

Inclusion Criteria

  • Meets the American College of Rheumatology (ACR) criteria for the diagnosis of rheumatoid arthritis (RA)
  • Stable disease activity, as evidenced by no change in immunomodulating or anti-inflammatory therapy in the 1 month before study entry
  • Moderate disease activity, as reflected by a minimum of three swollen and tender joints
  • If female of childbearing potential, willing to use effective method of contraception

Exclusion Criteria

  • Allergic to pioglitazone
  • Active cancer (other than skin cancer)
  • HIV infected
  • Currently receiving dialysis
  • Received an organ or bone marrow transplant
  • Heart failure
  • Severe edema, as judged by the principal investigator
  • Diabetes mellitus requiring drug therapy: levels of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than twice the upper limit of normal
  • Underwent major surgery in the 3 months before study entry
  • Severe comorbid condition that is likely to compromise survival or study participation
  • Currently receiving gemfibrozil or rifampin
  • Osteoporosis and not receiving osteoporosis medications
  • Unwillingness, or other inability, to cooperate with study procedures
  • Pregnancy
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00763139). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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