Trial Outcomes & Findings for Inflammation and Insulin Resistance in Rheumatoid Arthritis (NCT NCT00763139)

Last Updated: 2014-11-13

Results Overview

A measure of disease activity based upon tender joint count of 28 joints, swollen joint count of 28 joints, erythrocyte sedimentation rate, and global disease activity (GH) as reported by participant. Calculation is as follows: DAS28=0.56\*sqrt(t28) + 0.28\*sqrt(sw28) + 0.70\*Ln(ESR) + 0.014\*GH

Recruitment status

COMPLETED

Study phase

Target enrollment

34 participants

Primary outcome timeframe

Measured after 8 weeks of treatment

Results posted on

2014-11-13

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo 1st, Pioglitazone 2nd Placebo for first 8 weeks, then washout period for 4 weeks, and finally pioglitazone for 8 weeks. Pioglitazone: 45 mg by mouth once a day for 8 weeks Placebo: By mouth once a day for 8 weeks	Pioglitazone 1st, Placebo 2nd Pioglitazone for first 8 weeks, then washout period for 4 weeks, and finally placebo for 8 weeks. Pioglitazone: 45 mg by mouth once a day for 8 weeks Placebo: By mouth once a day for 8 weeks
Overall Study STARTED	17	17
Overall Study COMPLETED	12	14
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo 1st, Pioglitazone 2nd Placebo for first 8 weeks, then washout period for 4 weeks, and finally pioglitazone for 8 weeks. Pioglitazone: 45 mg by mouth once a day for 8 weeks Placebo: By mouth once a day for 8 weeks	Pioglitazone 1st, Placebo 2nd Pioglitazone for first 8 weeks, then washout period for 4 weeks, and finally placebo for 8 weeks. Pioglitazone: 45 mg by mouth once a day for 8 weeks Placebo: By mouth once a day for 8 weeks
Overall Study Adverse Event	4	2
Overall Study Withdrawal by Subject	0	1
Overall Study med change not allowed by protocol	1	0

Baseline Characteristics

Inflammation and Insulin Resistance in Rheumatoid Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Baseline Characteristics of Participants n=34 Participants participants who met American College of Rheumatology (ACR) criteria for rheumatoid arthritis (RA), age 18 or older, with moderate disease activity and no change in immunomodulating or anti-inflammatory therapy in past month
Age, Continuous	51.0 years STANDARD_DEVIATION 14.2 • n=93 Participants
Sex: Female, Male Female	28 Participants n=93 Participants
Sex: Female, Male Male	6 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants
Race (NIH/OMB) White	29 Participants n=93 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	34 participants n=93 Participants

PRIMARY outcome

Timeframe: Measured after 8 weeks of treatment

Outcome measures

Outcome measures
Measure	Pioglitazone Phase Baseline n=34 Participants All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Baseline results are reported here.	Pioglitazone Phase After 8 Weeks n=34 Participants All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Results after 8 weeks are reported here.	Placebo Phase Baseline n=34 Participants All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Baseline results are reported here.	Placebo Phase wk 8/20 n=34 Participants All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Results after 8 weeks are reported here.
Disease Activity Score Based on 28-joint Disease Activity Score (DAS28)	4.40 units on a scale Standard Deviation 1	4.03 units on a scale Standard Deviation 1.15	4.57 units on a scale Standard Deviation 1.28	4.48 units on a scale Standard Deviation 1.20

PRIMARY outcome

Timeframe: Measured after 8 weeks of treatment

Homa is a measure of insulin sensitivity, using glucose measured in mmol/L and insulin measured in milliUnits per liter (mU/L) Calculated using the formula Glucose \* Insulin/22/5

Outcome measures

Outcome measures
Measure	Pioglitazone Phase Baseline n=34 Participants All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Baseline results are reported here.	Pioglitazone Phase After 8 Weeks n=34 Participants All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Results after 8 weeks are reported here.	Placebo Phase Baseline n=34 Participants All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Baseline results are reported here.	Placebo Phase wk 8/20 n=34 Participants All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Results after 8 weeks are reported here.
Homeostasis Model Assessment (HOMA) for Insulin Sensitivity	2.83 units on a scale Standard Deviation 2.5	2.44 units on a scale Standard Deviation 2.08	2.38 units on a scale Standard Deviation 1.75	3.11 units on a scale Standard Deviation 3.47

SECONDARY outcome

Timeframe: Measured after 8 weeks of treatment

Outcome measures

Outcome measures
Measure	Pioglitazone Phase Baseline n=34 Participants All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Baseline results are reported here.	Pioglitazone Phase After 8 Weeks n=34 Participants All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Results after 8 weeks are reported here.	Placebo Phase Baseline n=34 Participants All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Baseline results are reported here.	Placebo Phase wk 8/20 n=34 Participants All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Results after 8 weeks are reported here.
C-reactive Protein (CRP)	8.1 mg/dl Standard Deviation 11.41	5.02 mg/dl Standard Deviation 7.64	7.7 mg/dl Standard Deviation 13.6	8.25 mg/dl Standard Deviation 10.32

SECONDARY outcome

Timeframe: baseline and after 8 weeks on either placebo or pioglitazone

sed rate

Outcome measures

Outcome measures
Measure	Pioglitazone Phase Baseline n=34 Participants All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Baseline results are reported here.	Pioglitazone Phase After 8 Weeks n=34 Participants All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Results after 8 weeks are reported here.	Placebo Phase Baseline n=34 Participants All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Baseline results are reported here.	Placebo Phase wk 8/20 n=34 Participants All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Results after 8 weeks are reported here.
ESR	18.5 mm/hr Standard Deviation 18.2	17 mm/hr Standard Deviation 17.06	19.5 mm/hr Standard Deviation 20	18.88 mm/hr Standard Deviation 20.8

Adverse Events

Pioglitazone

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pioglitazone n=34 participants at risk participants who met ACR criteria for RA, age 18 or older, with moderate disease activity and no change in immunomodulating or anti-inflammatory therapy in past month, during the period they were taking pioglitazone	Placebo n=34 participants at risk participants who met ACR criteria for RA, age 18 or older, with moderate disease activity and no change in immunomodulating or anti-inflammatory therapy in past month, during the period they were taking placebo
Pregnancy, puerperium and perinatal conditions Pregnancy	0.00% 0/34 • Adverse Event data were collected over the course of the 20 week study.	5.9% 2/34 • Number of events 2 • Adverse Event data were collected over the course of the 20 week study.

Other adverse events

Other adverse events
Measure	Pioglitazone n=34 participants at risk participants who met ACR criteria for RA, age 18 or older, with moderate disease activity and no change in immunomodulating or anti-inflammatory therapy in past month, during the period they were taking pioglitazone	Placebo n=34 participants at risk participants who met ACR criteria for RA, age 18 or older, with moderate disease activity and no change in immunomodulating or anti-inflammatory therapy in past month, during the period they were taking placebo
Hepatobiliary disorders liver function tests elevated	5.9% 2/34 • Number of events 2 • Adverse Event data were collected over the course of the 20 week study.	2.9% 1/34 • Number of events 1 • Adverse Event data were collected over the course of the 20 week study.
General disorders ankle edema	8.8% 3/34 • Number of events 3 • Adverse Event data were collected over the course of the 20 week study.	5.9% 2/34 • Number of events 2 • Adverse Event data were collected over the course of the 20 week study.
Respiratory, thoracic and mediastinal disorders upper respiratory tract infection	5.9% 2/34 • Number of events 2 • Adverse Event data were collected over the course of the 20 week study.	8.8% 3/34 • Number of events 3 • Adverse Event data were collected over the course of the 20 week study.

Additional Information

Dr. Charles Michael Stein

Vanderbilt

Phone: 615-936-3420

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place