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Trial record 57 of 117 for:    "Connective Tissue Disease" | "Methylprednisolone"

A Study of MabThera/Rituxan (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis and Inadequate Response to DMARD Therapy

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ClinicalTrials.gov Identifier: NCT02006706
Recruitment Status : Completed
First Posted : December 10, 2013
Results First Posted : November 6, 2014
Last Update Posted : August 21, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: rituximab [MabThera/Rituxan]
Drug: methotrexate
Drug: methylprednisolone
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rituximab/Methylprednisolone/Methotrexate (MTX)
Hide Arm/Group Description Participants received rituximab 1000 milligrams (mg), intravaneously (IV), and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants also received MTX, 10 to 25 mg per week (at a stable dose at the discretion of investigator and in accordance with the local label), orally (or parenterally, as prescribed) and folate 5 mg per week, orally, for up to 24 weeks.
Period Title: Overall Study
Started 15
Completed 14
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Arm/Group Title Rituximab/Methylprednisolone/MTX
Hide Arm/Group Description Participants received rituximab 1000 mg, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants also received MTX, 10 to 25 mg per week (at a stable dose at the discretion of investigator and in accordance with the local label), orally (or parenterally, as prescribed) and folate 5 mg per week, orally, for up to 24 weeks.
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
Per-protocol (PP) population: The 14 enrolled participants who were compliant with the protocol and not lost to follow-up.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
52.29  (11.89)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
<=18 years
0
   0.0%
Between 18 and 65 years
13
  92.9%
>=65 years
1
   7.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
9
  64.3%
Male
5
  35.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
14
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
14
 100.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Serbia Number Analyzed 14 participants
14
1.Primary Outcome
Title Change From Baseline Disease Activity Score Based on 28-Joint Count (DAS28) at Week 24
Hide Description DAS28 was calculated from the number of swollen joints and painful joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant-rated arthritis activity assessment using visual analog scale [VAS]) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol (PP) Population: included all participants who received at least one dose of study drug and who did not have any protocol violations.
Arm/Group Title Rituximab/Methylprednisolone/MTX
Hide Arm/Group Description:
Participants received rituximab 1000 mg, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants also received MTX, 10 to 25 mg per week (at a stable dose at the discretion of investigator and in accordance with the local label), orally (or parenterally, as prescribed) and folate 5 mg per week, orally, for up to 24 weeks.
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.98  (1.80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rituximab/Methylprednisolone/MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.98
Confidence Interval (2-Sided) 95%
1.73 to 4.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.606
Estimation Comments The null hypothesis was that there was no difference between the DAS28 at baseline and DAS28 after 24 weeks of follow-up
2.Secondary Outcome
Title Health Assessment Questionnaire-Disability Index (HAQ-DI)
Hide Description HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population
Arm/Group Title Rituximab/Methylprednisolone/MTX
Hide Arm/Group Description:
Participants received rituximab 1000 mg, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants also received MTX, 10 to 25 mg per week (at a stable dose at the discretion of investigator and in accordance with the local label), orally (or parenterally, as prescribed) and folate 5 mg per week, orally, for up to 24 weeks.
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 1.91  (0.687)
Week 24 1.05  (0.960)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rituximab/Methylprednisolone/MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Adverse events (AEs) were reported starting with the first dose of study drug through the end of the study (24 weeks total).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rituximab/Methylprednisolone/MTX
Hide Arm/Group Description Participants received rituximab 1000 mg, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants also received MTX, 10 to 25 mg per week (at a stable dose at the discretion of investigator and in accordance with the local label), orally (or parenterally, as prescribed) and folate 5 mg per week, orally, for up to 24 weeks.
All-Cause Mortality
Rituximab/Methylprednisolone/MTX
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Rituximab/Methylprednisolone/MTX
Affected / at Risk (%)
Total   2/14 (14.29%) 
Cardiac disorders   
Infarctus myocardii * 1  1/14 (7.14%) 
Gastrointestinal disorders   
Enterocolitis acuta * 1  1/14 (7.14%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, NCI CTCAE v3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Rituximab/Methylprednisolone/MTX
Affected / at Risk (%)
Total   0/14 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request the Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Name/Title: Medical Communications
Organization: Hoffmann-LaRoche
Phone: 800-821-8590
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02006706     History of Changes
Other Study ID Numbers: ML20388
First Submitted: December 5, 2013
First Posted: December 10, 2013
Results First Submitted: October 31, 2014
Results First Posted: November 6, 2014
Last Update Posted: August 21, 2017