Trial Outcomes & Findings for A Safety Analysis of Oral Prednisone as a Pre-Treatment for Rituximab in Rheumatoid Arthritis. (NCT NCT00580229)

Last Updated: 2018-07-26

Results Overview

Open-label assessment of AIR's during and/or within 24 hours in patients pretreated with 40mg oral prednisone 30 minutes prior to initial rituximab infusion

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

50 participants

Primary outcome timeframe

24 hours

Results posted on

2018-07-26

Participant Flow

From February 2008 to January 2011 in the medical clinic.

All study participants were treated with open-label standard dose and the recommended infusions of rituximab for rheumatoid arthritis.

Participant milestones

Participant milestones
Measure	Oral Prednisone as a Pretreatment to Rituximab 40mg of oral prednisone given 30 min prior to rituximab as a prophylaxis against acute infusion reactions(AIR), as an alternative to the intravenous methylprednisone as a pretreatment for rituximab.
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Safety Analysis of Oral Prednisone as a Pre-Treatment for Rituximab in Rheumatoid Arthritis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oral Prednisone as a Pretreatment to Rituximab n=50 Participants 40mg of oral prednisone given 30 min prior to rituximab as a prophylaxis against acute infusion reactions(AIR), as an alternative to the intravenous methylprednisone as a pretreatment for rituximab.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	48 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	27 years STANDARD_DEVIATION 28 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: The subjects were 18-80 years of age, and fulfilled the 1987 American College of Rheumatology Criteria for Rheumatoid Arthritis, and taking concomitant methotrexate.

Open-label assessment of AIR's during and/or within 24 hours in patients pretreated with 40mg oral prednisone 30 minutes prior to initial rituximab infusion

Outcome measures

Outcome measures
Measure	Oral Prednisone as a Pretreatment to Rituximab n=50 Participants 40mg of oral prednisone given 30 min prior to rituximab as a prophylaxis against acute infusion reactions(AIR), as an alternative to the intravenous methylprednisone as a pretreatment for rituximab.
Number of Acute Infusion Reactions in the First 24 Hours After Oral Prednisone Pretreatment to Initial Rituximab Infusion	50 acute infusion reactions

SECONDARY outcome

Timeframe: 24 hours

Assessment of all adverse infusion reactions within 24 hours of receipt of the second rituximab infusion

Outcome measures

Outcome measures
Measure	Oral Prednisone as a Pretreatment to Rituximab n=48 Participants 40mg of oral prednisone given 30 min prior to rituximab as a prophylaxis against acute infusion reactions(AIR), as an alternative to the intravenous methylprednisone as a pretreatment for rituximab.
Adverse Infusion Reactions Within 24 Hours Following the Second Rituximab Infusion.	48 acute infusion reactions

SECONDARY outcome

Timeframe: 24 weeks

All adverse events reported from day 15 (24 hours after second infusion) through week 26.

Outcome measures

Outcome measures
Measure	Oral Prednisone as a Pretreatment to Rituximab n=48 Participants 40mg of oral prednisone given 30 min prior to rituximab as a prophylaxis against acute infusion reactions(AIR), as an alternative to the intravenous methylprednisone as a pretreatment for rituximab.
Adverse Events Assessed From Day 15 Through Week 26.	48 events

Adverse Events

Oral Prednisone as a Pretreatment to Rituximab

Serious events: 3 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Oral Prednisone as a Pretreatment to Rituximab n=50 participants at risk 40mg of oral prednisone given 30 min prior to rituximab as a prophylaxis against acute infusion reactions(AIR), as an alternative to the intravenous methylprednisone as a pretreatment for rituximab.
Cardiac disorders atrial fibrillation	2.0% 1/50 • Number of events 1
Respiratory, thoracic and mediastinal disorders asthma exacerbation	2.0% 1/50 • Number of events 50
Psychiatric disorders suicide attempt	2.0% 1/50 • Number of events 50

Other adverse events

Other adverse events
Measure	Oral Prednisone as a Pretreatment to Rituximab n=50 participants at risk 40mg of oral prednisone given 30 min prior to rituximab as a prophylaxis against acute infusion reactions(AIR), as an alternative to the intravenous methylprednisone as a pretreatment for rituximab.
Respiratory, thoracic and mediastinal disorders upper respiratory infection	24.0% 12/50
Respiratory, thoracic and mediastinal disorders sinusitis	6.0% 3/50
General disorders headache	6.0% 3/50
Musculoskeletal and connective tissue disorders backache	4.0% 2/50
Gastrointestinal disorders diarrhea	4.0% 2/50
Injury, poisoning and procedural complications fall	4.0% 2/50
Nervous system disorders fibromyalgia flare	4.0% 2/50
Musculoskeletal and connective tissue disorders fracture	4.0% 2/50
Gastrointestinal disorders nausea	4.0% 2/50
Skin and subcutaneous tissue disorders rash	4.0% 2/50

Additional Information

John D. Carter, M.D.

University of South Florida

Phone: 813-974-2681

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60