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A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01000610
Recruitment Status : Completed
First Posted : October 23, 2009
Results First Posted : March 19, 2015
Last Update Posted : August 16, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: N/A;   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 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rituximab
Hide Arm/Group Description Participants received rituximab 1000 milligrams (mg) intravenous (iv) infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (less than or equal to [≤] 10 milligrams per day (mg/day) prednisone or equivalent) or intra-articular corticosteroids, non-steroid anti-inflammatory drugs (NSAIDs) and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone100 mg iv prior to each rituximab infusion.
Period Title: Overall Study
Started 18
Completed 12
Not Completed 6
Reason Not Completed
Adverse Event             1
Lost to Follow-up             4
Treatment failure             1
Arm/Group Title Rituximab
Hide Arm/Group Description Participants received rituximab 1000 mg iv infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (≤ 10 mg/day prednisone or equivalent) or intra-articular corticosteroids, NSAIDs and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone 100 mg iv prior to each rituximab infusion.
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
Intent-to-Treat (ITT) population: All participants who received any part of an infusion have been included in the ITT analysis. Participants who prematurely withdrew from the study for any reason and for whom an assessment was not performed for whatever reason, were still included in the ITT analyses.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
53.4  (7.91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
16
  88.9%
Male
2
  11.1%
1.Primary Outcome
Title Number of Participants Reporting Adverse Events (AEs)
Hide Description [Not Specified]
Time Frame Days 1 and 15, every 8 weeks up to Week 24 and and then every 3 months up to 18 months for a total of 104 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: Included all participants who have received any part of an infusion of study medication.
Arm/Group Title Rituximab
Hide Arm/Group Description:
Participants received rituximab 1000 mg iv infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (≤ 10 mg/day prednisone or equivalent) or intra-articular corticosteroids, NSAIDs and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone 100 mg iv prior to each rituximab infusion.
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: number of participants
Participants who experienced an AE 11
Participants who experienced more than 1 AE 7
2.Secondary Outcome
Title Percentage Change in Disease Activity Score 28 (DAS28) From Baseline to Week 24
Hide Description The DAS28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], participant's global assessment of disease activity [visual analog scale: [VAS] 0 equals (=) no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to 10. Scores less than (<) 2.6 indicate best disease control and scores greater than or equal to (≥) 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6. The average improvement at each visit to the group score is equal to the formula (Previous DAS28 minus [-] current DAS 28)/ Previous DAS 28 x 100. Negative percentages indicate that the participant has worsened in comparison to last evaluation, and positive percentages indicate improvement of its DAS28 score and correlated with a bettering of clinical situation.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; Only participants with DAS28 values at both Baseline and Week 24 were included in the analysis.
Arm/Group Title Rituximab
Hide Arm/Group Description:
Participants received rituximab 1000 mg iv infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (≤ 10 mg/day prednisone or equivalent) or intra-articular corticosteroids, NSAIDs and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone 100 mg iv prior to each rituximab infusion.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: percentage change from baseline
-1.7  (49.4)
3.Secondary Outcome
Title Percentage of Participants Whose DAS28 Improved by >1.2 at Week 24
Hide Description The DAS28 score is a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], participant's global assessment of disease activity [VAS: 0 = no disease activity to 100 = maximum disease activity] and the ESR for a total possible score of 0 to 10. Scores < 2.6 indicate best disease control and scores ≥ 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6. An improvement of >1.2 was considered to be clinically significant improvement.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; Only participants with DAS28 values at both Baseline and Week 24 were included in the analysis.
Arm/Group Title Rituximab
Hide Arm/Group Description:
Participants received rituximab 1000 mg iv infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (≤ 10 mg/day prednisone or equivalent) or intra-articular corticosteroids, NSAIDs and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone 100 mg iv prior to each rituximab infusion.
Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: percentage of participants
75.0
4.Secondary Outcome
Title Change in Bone Density (in Participants Untreated With Bisphosphonates)
Hide Description Bone mineral density test was performed using x-ray radiation and the values of bone density were provided directly by the apparatus as grams per square centimeter (g/cm^2) . T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis.
Time Frame Screening and Week 84
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; only participants with an assessment at both screening and Week 84 were included in the analysis.
Arm/Group Title Rituximab
Hide Arm/Group Description:
Participants received rituximab 1000 mg iv infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (≤ 10 mg/day prednisone or equivalent) or intra-articular corticosteroids, NSAIDs and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone 100 mg iv prior to each rituximab infusion.
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: t-score
Screening -1.82
Week 84 -1.6
Time Frame AEs were recorded from the day of first infusion until the End of Study at 104 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rituximab
Hide Arm/Group Description Participants received rituximab 1000 mg iv infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (≤ 10 mg/day prednisone or equivalent) or intra-articular corticosteroids, NSAIDs and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone 100 mg iv prior to each rituximab infusion.
All-Cause Mortality
Rituximab
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Rituximab
Affected / at Risk (%)
Total   6/18 (33.33%) 
Blood and lymphatic system disorders   
Persistent thrombopenia * 1  1/18 (5.56%) 
Cardiac disorders   
Ventricular Extra systolebigeminy * 1  1/18 (5.56%) 
Gastrointestinal disorders   
Rectal bleeding * 1  1/18 (5.56%) 
Injury, poisoning and procedural complications   
Severe infusion reaction * 1  1/18 (5.56%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism * 1  1/18 (5.56%) 
Dyspnea * 1  1/18 (5.56%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (Unspecified)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Rituximab
Affected / at Risk (%)
Total   9/18 (50.00%) 
Blood and lymphatic system disorders   
Hypertension * 1  2/18 (11.11%) 
Ear and labyrinth disorders   
Vertigo * 1  1/18 (5.56%) 
Endocrine disorders   
Hyperglycemia * 1  1/18 (5.56%) 
Eye disorders   
Blurred Vision * 1  1/18 (5.56%) 
General disorders   
Red Throat * 1  1/18 (5.56%) 
Somnolence * 1  1/18 (5.56%) 
Nocturnal Sweating * 1  1/18 (5.56%) 
Headache * 1  1/18 (5.56%) 
Infections and infestations   
Multi-sensitive Streptococcus Cystitis * 1  1/18 (5.56%) 
Influenza * 1  1/18 (5.56%) 
Pneumopathy Infection * 1  1/18 (5.56%) 
Musculoskeletal and connective tissue disorders   
Muscular Pain * 1  1/18 (5.56%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea Stage 2 * 1  1/18 (5.56%) 
Productive Cough-Yellow Expectorations * 1  1/18 (5.56%) 
Skin and subcutaneous tissue disorders   
Keratitis Secca * 1  1/18 (5.56%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (Unspecified)
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 that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann- LaRoche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01000610    
Other Study ID Numbers: ML20549
First Submitted: October 21, 2009
First Posted: October 23, 2009
Results First Submitted: February 27, 2015
Results First Posted: March 19, 2015
Last Update Posted: August 16, 2017