Trial Outcomes & Findings for A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate (NCT NCT00934648)

NCT ID: NCT00934648

Last Updated: 2014-06-10

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 15 participants
• Primary outcome timeframe: Week 104
• Results posted on: 2014-06-10

Participant Flow

Participant milestones

Measure	Rituximab 1000 Milligrams (mg) Participants received rituximab 1000 mg administered intravenously (IV) and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background methotrexate (MTX) 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
Overall Study STARTED	15
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Measure	Rituximab 1000 Milligrams (mg) Participants received rituximab 1000 mg administered intravenously (IV) and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background methotrexate (MTX) 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
Overall Study Failure to return	8
Overall Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Rituximab 1000 mg n=15 Participants Participants received rituximab 1000 mg administered IV and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background MTX 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
Age, Continuous	37 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 104

Population: Safety population: included all participants who have received any part of an infusion of the study medication.

Outcome measures

Measure	Rituximab 1000 mg n=15 Participants Participants received rituximab 1000 mg administered IV and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background MTX 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
Percentage of Participants With an Adverse Event (AE)	26.7 percentage of participants

SECONDARY outcome

Timeframe: Day 1 and Week 24

Population: ITT population

DAS28 was calculated from the number of swollen joints and tender joints using the 28 joint count; the erythrocyte sedimentation rate (ESR) measured in millimeters per hour [mm/hr]); and the Patient's Global Assessment of disease activity (participant-rated visual analog assessment [VAS]) with transformed scores with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Overall, a DAS28 score of less than or equal to (≤) 3.2 equals (=) low disease activity, and a DAS28 score of greater than (>) 3.2 to 5.1 = moderate to high disease activity.

Outcome measures

Measure	Rituximab 1000 mg n=15 Participants Participants received rituximab 1000 mg administered IV and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background MTX 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
Disease Activity Score Based on 28-Joint Count (DAS28) Day 1	5.79 scores on a scale Standard Deviation 1.03
Disease Activity Score Based on 28-Joint Count (DAS28) Week 24	4.41 scores on a scale Standard Deviation 1.88

SECONDARY outcome

Timeframe: Screening, Day 1, and Weeks 24 and 104

Population: ITT population

DAS28-based EULAR response criteria were used to measure individual response as no response, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline greater than (>)1.2 with DAS28 less than or equal to (≤)3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to ≤1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with DAS28 >5.1.

Outcome measures

Measure	Rituximab 1000 mg n=15 Participants Participants received rituximab 1000 mg administered IV and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background MTX 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
Percentage of Participants With a DAS28 Response by European League Against Rheumatism (EULAR) Category ≤3.2 at Screening	0 percentage of participants
Percentage of Participants With a DAS28 Response by European League Against Rheumatism (EULAR) Category >3.2 and ≤5.1 at Screening	22.2 percentage of participants
Percentage of Participants With a DAS28 Response by European League Against Rheumatism (EULAR) Category >5.1 at Screening	77.8 percentage of participants
Percentage of Participants With a DAS28 Response by European League Against Rheumatism (EULAR) Category ≤3.2 at Day 1	0 percentage of participants
Percentage of Participants With a DAS28 Response by European League Against Rheumatism (EULAR) Category >3.2 and ≤5.1 at Day 1	33.3 percentage of participants
Percentage of Participants With a DAS28 Response by European League Against Rheumatism (EULAR) Category >5.1 at Day 1	66.7 percentage of participants
Percentage of Participants With a DAS28 Response by European League Against Rheumatism (EULAR) Category ≤3.2 at Week 24	37.5 percentage of participants
Percentage of Participants With a DAS28 Response by European League Against Rheumatism (EULAR) Category >3.2 and ≤5.1 at Week 24	37.5 percentage of participants
Percentage of Participants With a DAS28 Response by European League Against Rheumatism (EULAR) Category >5.1 at Week 24	25.0 percentage of participants
Percentage of Participants With a DAS28 Response by European League Against Rheumatism (EULAR) Category ≤3.2 at Week 104	33.3 percentage of participants
Percentage of Participants With a DAS28 Response by European League Against Rheumatism (EULAR) Category >3.2 and ≤5.1 at Week 104	33.3 percentage of participants
Percentage of Participants With a DAS28 Response by European League Against Rheumatism (EULAR) Category >5.1 at Week 104	33.3 percentage of participants

SECONDARY outcome

Timeframe: Screening, Weeks 48 and 104

Population: ITT population

Change in bone density in participants untreated with bisphosphonates was classified as percentage of participants with osteoporosis, osteopenia, or normal. In some participants, no determinations were available.

Outcome measures

Measure	Rituximab 1000 mg n=15 Participants Participants received rituximab 1000 mg administered IV and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background MTX 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
Percentage of Participants With Changes in Bone Density Osteoporosis, Screening	20 percentage of participants
Percentage of Participants With Changes in Bone Density Osteopenia, Screening	46.7 percentage of participants
Percentage of Participants With Changes in Bone Density Normal, Screening	0 percentage of participants
Percentage of Participants With Changes in Bone Density Not determined, Screening	33.3 percentage of participants
Percentage of Participants With Changes in Bone Density Osteoporosis, Week 48	6.7 percentage of participants
Percentage of Participants With Changes in Bone Density Osteopenia, Week 48	13.3 percentage of participants
Percentage of Participants With Changes in Bone Density Normal, Week 48	6.7 percentage of participants
Percentage of Participants With Changes in Bone Density Not determined, Week 48	73.3 percentage of participants
Percentage of Participants With Changes in Bone Density Osteoporosis, Week 104	0 percentage of participants
Percentage of Participants With Changes in Bone Density Osteopenia, Week 104	40 percentage of participants
Percentage of Participants With Changes in Bone Density Normal, Week 104	0 percentage of participants
Percentage of Participants With Changes in Bone Density Not determined, Week 104	60 percentage of participants

Adverse Events

Rituximab 1000 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Rituximab 1000 mg n=15 participants at risk Participants received rituximab 1000 mg administered IV and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background MTX 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
General disorders Fever	6.7% 1/15 • Adverse events were collected from signing of informed consent through the end of the follow-up period (Week 104).
Infections and infestations Scalp infection	6.7% 1/15 • Adverse events were collected from signing of informed consent through the end of the follow-up period (Week 104).
Skin and subcutaneous tissue disorders Rash	6.7% 1/15 • Adverse events were collected from signing of informed consent through the end of the follow-up period (Week 104).
Skin and subcutaneous tissue disorders Rash of face	6.7% 1/15 • Adverse events were collected from signing of informed consent through the end of the follow-up period (Week 104).
Skin and subcutaneous tissue disorders Diffuse skin rash	6.7% 1/15 • Adverse events were collected from signing of informed consent through the end of the follow-up period (Week 104).
Respiratory, thoracic and mediastinal disorders Dyspnea	6.7% 1/15 • Adverse events were collected from signing of informed consent through the end of the follow-up period (Week 104).
Respiratory, thoracic and mediastinal disorders Tightening of throat and tongue	6.7% 1/15 • Adverse events were collected from signing of informed consent through the end of the follow-up period (Week 104).
Respiratory, thoracic and mediastinal disorders Difficulty breathing	6.7% 1/15 • Adverse events were collected from signing of informed consent through the end of the follow-up period (Week 104).

Additional Information

Medical Communications

Hoffmann-LaRoche

Phone: 800-821-8590

Email: genentech@druginfo.com

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