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Trial Outcomes & Findings for Tocilizumab Plus a Short Prednisone Taper for GCA (NCT NCT03726749)

NCT ID: NCT03726749

Last Updated: 2022-12-02

Results Overview

Number and percentage of patients in sustained remission by week 52. Sustained remission was defined as the absence of disease flare between baseline and week 52. Flare was defined as the re-appearance of clinical manifestations of GCA with or without elevation of the inflammatory makers erythrocyte sedimentation rate (ESR) and/or C-reactive protein (CRP)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

52 weeks

Results posted on

2022-12-02

Participant Flow

Participant milestones

Participant milestones
Measure
Tocilizumab and Prednisone
1. TCZ 162 mg administered by subcutaneous injection weekly for 52 weeks. 2. Prednisone taper over 8 weeks with a starting dose between 20 and 60 mg. Tocilizumab: Tocilizumab is an interleukin-6 (IL-6) receptor inhibitor Prednisone: Prednisone is an anti-inflammatory medication
Overall Study
STARTED
30
Overall Study
COMPLETED
30
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tocilizumab Plus a Short Prednisone Taper for GCA

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Tocilizumab and Prednisone
n=30 Participants
1. TCZ 162 mg administered by subcutaneous injection weekly for 52 weeks. 2. Prednisone taper over 8 weeks with a starting dose between 20 and 60 mg. Tocilizumab: Tocilizumab is an interleukin-6 (IL-6) receptor inhibitor Prednisone: Prednisone is an anti-inflammatory medication
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
4 Participants
n=5 Participants
Age, Categorical
>=65 years
26 Participants
n=5 Participants
Age, Continuous
73.7 years
STANDARD_DEVIATION 8.1 • n=5 Participants
Sex: Female, Male
Female
18 Participants
n=5 Participants
Sex: Female, Male
Male
12 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
Race (NIH/OMB)
White
30 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
30 participants
n=5 Participants

PRIMARY outcome

Timeframe: 52 weeks

Number and percentage of patients in sustained remission by week 52. Sustained remission was defined as the absence of disease flare between baseline and week 52. Flare was defined as the re-appearance of clinical manifestations of GCA with or without elevation of the inflammatory makers erythrocyte sedimentation rate (ESR) and/or C-reactive protein (CRP)

Outcome measures

Outcome measures
Measure
Tocilizumab and Prednisone
n=30 Participants
1. TCZ 162 mg administered by subcutaneous injection weekly for 52 weeks. 2. Prednisone taper over 8 weeks with a starting dose between 20 and 60 mg. Tocilizumab: Tocilizumab is an interleukin-6 (IL-6) receptor inhibitor Prednisone: Prednisone is an anti-inflammatory medication
Sustained Remission
23 Participants

SECONDARY outcome

Timeframe: 52 Weeks

Total number of disease flares by week 52. Flare was defined as the re-appearance of clinical manifestations of GCA with or without elevation of the inflammatory makers erythrocyte sedimentation rate (ESR) and/or C-reactive protein (CRP)

Outcome measures

Outcome measures
Measure
Tocilizumab and Prednisone
n=30 Participants
1. TCZ 162 mg administered by subcutaneous injection weekly for 52 weeks. 2. Prednisone taper over 8 weeks with a starting dose between 20 and 60 mg. Tocilizumab: Tocilizumab is an interleukin-6 (IL-6) receptor inhibitor Prednisone: Prednisone is an anti-inflammatory medication
Disease Flares
9 Total number of flares

SECONDARY outcome

Timeframe: 52 Weeks

Cumulative prednisone dose (mg) by week 52

Outcome measures

Outcome measures
Measure
Tocilizumab and Prednisone
n=30 Participants
1. TCZ 162 mg administered by subcutaneous injection weekly for 52 weeks. 2. Prednisone taper over 8 weeks with a starting dose between 20 and 60 mg. Tocilizumab: Tocilizumab is an interleukin-6 (IL-6) receptor inhibitor Prednisone: Prednisone is an anti-inflammatory medication
Cumulative Prednisone Dose
1187 mg
Standard Deviation 470.4

SECONDARY outcome

Timeframe: 52 weeks

Number and percentage of participants with at least one adverse event by week 52

Outcome measures

Outcome measures
Measure
Tocilizumab and Prednisone
n=30 Participants
1. TCZ 162 mg administered by subcutaneous injection weekly for 52 weeks. 2. Prednisone taper over 8 weeks with a starting dose between 20 and 60 mg. Tocilizumab: Tocilizumab is an interleukin-6 (IL-6) receptor inhibitor Prednisone: Prednisone is an anti-inflammatory medication
Adverse Events
30 Participants

SECONDARY outcome

Timeframe: 52 weeks

Number and percentage of participants with at least one serious adverse event by week 52

Outcome measures

Outcome measures
Measure
Tocilizumab and Prednisone
n=30 Participants
1. TCZ 162 mg administered by subcutaneous injection weekly for 52 weeks. 2. Prednisone taper over 8 weeks with a starting dose between 20 and 60 mg. Tocilizumab: Tocilizumab is an interleukin-6 (IL-6) receptor inhibitor Prednisone: Prednisone is an anti-inflammatory medication
Serious Adverse Events
4 Participants

Adverse Events

Tocilizumab and Prednisone

Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Tocilizumab and Prednisone
n=30 participants at risk
1. TCZ 162 mg administered by subcutaneous injection weekly for 52 weeks. 2. Prednisone taper over 8 weeks with a starting dose between 20 and 60 mg. Tocilizumab: Tocilizumab is an interleukin-6 (IL-6) receptor inhibitor Prednisone: Prednisone is an anti-inflammatory medication
Infections and infestations
Olecranon bursitis, septic
3.3%
1/30 • Number of events 1 • 2.2 years
Gastrointestinal disorders
Diverticulitis
3.3%
1/30 • Number of events 1 • 2.2 years
Gastrointestinal disorders
Cholecystitis
3.3%
1/30 • Number of events 1 • 2.2 years
Endocrine disorders
Osteoporotic vertebral fracture
3.3%
1/30 • Number of events 1 • 2.2 years

Other adverse events

Adverse event data not reported

Additional Information

Dr Sebastian Unizony

MGH

Phone: 617-726-7938

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place