Trial Outcomes & Findings for A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a TNF-Blocker. (NCT NCT00424502)

Last Updated: 2016-05-09

Results Overview

DAS28 consists of swollen joint count (SJC) and tender joint count (TJC) measurements, erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hr\]), and Patient Global Assessment of Disease Activity (participant-rated assessment of arthritis) with transformed scores ranging from 0 to 10. Higher scores indicated greater affectation due to disease activity. DAS28 equal to or less than (≤)3.2 equals (=) low disease activity, greater than (\>)3.2 to 5.1 = moderate to high disease activity.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

Day 0 and Week 24

Results posted on

2016-05-09

Participant Flow

Participant milestones

Participant milestones
Measure	Rituximab 1000 Milligrams (mg) Participants received rituximab 1000 mg intravenously (IV) and methylprednisolone 100 mg IV on Days 0 and 14.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a TNF-Blocker.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rituximab 1000 mg n=20 Participants Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
Age, Continuous	48.70 years STANDARD_DEVIATION 12.88 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0 and Week 24

Population: All enrolled participants who received at least one dose of study treatment.

Outcome measures

Outcome measures
Measure	Rituximab 1000 mg n=20 Participants Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
Disease Activity Score Based on 28-Joint Count (DAS28) Day 0	6.03 units on a scale Standard Deviation 0.96
Disease Activity Score Based on 28-Joint Count (DAS28) Week 24	4.01 units on a scale Standard Deviation 1.49

SECONDARY outcome

Timeframe: Day 0 and Week 24

Population: All enrolled participants. n (number) = number of participants assessed for the specified parameter at a given visit.

The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. For each of the categories, participants reported the amount of difficulty they had in performing 2 or 3 specific subcategory items. The standard disability score was calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered, yielding a score from 0 (without any difficulty) to 3 (unable to do).

Outcome measures

Outcome measures
Measure	Rituximab 1000 mg n=20 Participants Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
Health Assessment Questionnaire - Disability Index (HAQ-DI) Scores Week 24 (n=19)	0.87 units on a scale Standard Deviation 0.36
Health Assessment Questionnaire - Disability Index (HAQ-DI) Scores Day 0 (n=20)	1.14 units on a scale Standard Deviation 0.31

SECONDARY outcome

Timeframe: Day 0 and Week 24

Population: All participants who received at least 1 dose of study drug; n=number of participants assessed for the specified parameter at a given visit.

Anti-CCP measured as absorbance units per milliliter (AU/mL).

Outcome measures

Outcome measures
Measure	Rituximab 1000 mg n=20 Participants Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
Anti-cyclic Citrullinated Peptide (Anti-CCP) Day 0 (n=20)	731.07 AU/mL Standard Deviation 569.83
Anti-cyclic Citrullinated Peptide (Anti-CCP) Week 24 (n=19)	846.41 AU/mL Standard Deviation 988.18

SECONDARY outcome

Timeframe: Day 0 and Week 24

Population: All participants who received at least 1 dose of study drug.

VEGF was measured as picograms per milliliter (pg/mL).

Outcome measures

Outcome measures
Measure	Rituximab 1000 mg n=20 Participants Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
Vascular Endothelial Growth Factor (VEGF) Day 0	516.68 pg/mL Standard Deviation 523.89
Vascular Endothelial Growth Factor (VEGF) Week 24	520.15 pg/mL Standard Deviation 451.10

SECONDARY outcome

Timeframe: Day 0 and Week 24

Population: All participants who received at least 1 dose of study drug.

ESR was measured in mm/hr.

Outcome measures

Outcome measures
Measure	Rituximab 1000 mg n=20 Participants Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
Erythrocyte Sedimentation Rate (ESR) Day 0	45.25 mm/hr Standard Deviation 22.40
Erythrocyte Sedimentation Rate (ESR) Week 24	30.85 mm/hr Standard Deviation 4.58

SECONDARY outcome

Timeframe: Day 0 and Week 24

Population: All participants who received at least 1 dose of study drug.

CRP was measured in milligrams per liter (mg/L).

Outcome measures

Outcome measures
Measure	Rituximab 1000 mg n=20 Participants Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
C-Reactive Protein (CRP) Day 0	6.13 mg/L Standard Deviation 9.77
C-Reactive Protein (CRP) Week 24	4.32 mg/L Standard Deviation 6.51

Adverse Events

Rituximab 1000 mg

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Rituximab 1000 mg n=20 participants at risk Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
Psychiatric disorders Mood change	5.0% 1/20 • Adverse events (AEs) and serious AEs (SAEs) were reported up to Week 48.
Skin and subcutaneous tissue disorders Skin lesion	5.0% 1/20 • Adverse events (AEs) and serious AEs (SAEs) were reported up to Week 48.
Gastrointestinal disorders Blood in stool	5.0% 1/20 • Adverse events (AEs) and serious AEs (SAEs) were reported up to Week 48.
Respiratory, thoracic and mediastinal disorders Cough	5.0% 1/20 • Adverse events (AEs) and serious AEs (SAEs) were reported up to Week 48.
Gastrointestinal disorders Throat pain	10.0% 2/20 • Adverse events (AEs) and serious AEs (SAEs) were reported up to Week 48.
General disorders Fever	10.0% 2/20 • Adverse events (AEs) and serious AEs (SAEs) were reported up to Week 48.
Eye disorders Dry eye sensation	5.0% 1/20 • Adverse events (AEs) and serious AEs (SAEs) were reported up to Week 48.
Eye disorders Blurred vision	5.0% 1/20 • Adverse events (AEs) and serious AEs (SAEs) were reported up to Week 48.
General disorders Feeling of weakness	5.0% 1/20 • Adverse events (AEs) and serious AEs (SAEs) were reported up to Week 48.
Psychiatric disorders Sleep disturbance	5.0% 1/20 • Adverse events (AEs) and serious AEs (SAEs) were reported up to Week 48.
Blood and lymphatic system disorders Leucopenia	5.0% 1/20 • Adverse events (AEs) and serious AEs (SAEs) were reported up to Week 48.
Infections and infestations Upper respiratory tract infection	10.0% 2/20 • Adverse events (AEs) and serious AEs (SAEs) were reported up to Week 48.
Musculoskeletal and connective tissue disorders Progression of rheumatoid arthritis	5.0% 1/20 • Adverse events (AEs) and serious AEs (SAEs) were reported up to Week 48.
Blood and lymphatic system disorders Haemorrhagic suffusion	5.0% 1/20 • Adverse events (AEs) and serious AEs (SAEs) were reported up to Week 48.
Eye disorders Acute conjunctivitis	5.0% 1/20 • Adverse events (AEs) and serious AEs (SAEs) were reported up to Week 48.
Injury, poisoning and procedural complications Infusion site pruritus	5.0% 1/20 • Adverse events (AEs) and serious AEs (SAEs) were reported up to Week 48.
Injury, poisoning and procedural complications Infusion site swelling	5.0% 1/20 • Adverse events (AEs) and serious AEs (SAEs) were reported up to Week 48.

Additional Information

Medical Communications

Hoffmann-LaRoche

Phone: 800-821-8590

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER