Clinical Trial Summary Tool

Rituxan in Clinical Trials

Select up to 3 clinical trials and compare objectives, trial design, and end points

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REFLEX: Rituxan-Approved for retreatment at 6- month intervals

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial Evaluating Primary Efficacy and Safety at 24 Weeks

To determine the efficacy and safety of treatment with rituximab plus methotrexate in patients with active RA who had an inadequate response to prior TNFi therapies
To explore the pharmacokinetics and pharmacodynamics of rituximab in this population

Phase 3 randomized, double-blind, placebo-controlled ITT analysis
Primary efficacy and safety were evaluated at 24 weeks
After 24 weeks, patients entered a posttreatment period and had follow-up evaluations every 2 months for 18 months, for an overall study duration of 24 months

N=520
Patients were randomized at a ratio of 3:2 to receive IV infusions of rituximab or placebo on Days 1 and 15
Both groups continued to take stable doses of methotrexate

The primary end point was the proportion of patients with an ACR 20 response at Week 24
Secondary end points included ACR 50 and ACR 70 responses, changes from baseline to Week 24 in DAS28 score, EULAR response criteria, and the individual parameters of the ACR improvement criteria
Additional end points included changes from baseline to Week 24 in the FACIT-F score, the SF-36, and the Genant-modified Sharp radiographic score
Data were collected on overall and serious adverse events, infusion-related reactions, infections and serious infections, cardiovascular events and malignancies

Source: Cohen SB, Emery P, Greenwald MW, et al; for the REFLEX Trial Group. Arthritis Rheum. 2006;54(9):2793-2806.

REFLEX: 2-year joint protection data (A subanalysis of Study 1 in Rituxan Prescribing Information)

Continued Inhibition of Structural Damage in RA Patients Treated With Rituximab at 2 Years

To determine whether inhibition of structural damage is maintained through 2 years of treatment

Patients drawn from REFLEX study
Analyzed according to the ITT principle

Baseline and postbaseline (24 or 56 week) X-ray and Week 104 X-ray
Patients must have baseline and at least 1 postbaseline X-ray
Radiographs taken at 24, 56, and 104 weeks
Linear extrapolation used for patients missing Week 104 data

Primary radiographic end point: Mean change at 2 years vs baseline in Genant-modified Sharp score
Secondary radiographic end points included erosion score, joint–spacenarrowing score, and proportion of patients with no further joint progression

Source: Cohen SB, Keystone E, Genovese MC, et al. Ann Rheum Dis. 2010 May 3. [Epub ahead of print]. doi: 10.1136/ard.2009.119222

van Vollenhoven: Long-term Safety in clinical trials

Long-term Safety of Patients Receiving Rituximab in RA Clinical Trials

To evaluate the long-term safety of rituximab in patients with RA in clinical trials

Pooled analysis of safety data, including adverse events and infections, from patients treated with rituximab plus methotrexate in global clinical trials

Patients received rituximab or placebo in original study, followed by rituximab as rescue therapy or part of open-label extension study
The placebo population comprised all patients who received a placebo infusion who either did not or had not yet received rituximab, together with data from patients who received placebo and were subsequently exposed to rituximab
Patients were drawn from the following studies: REFLEX, SERENE, SUNRISE, MIRROR, SIERRA, DANCER, Edwards (IIa), and the DANCER/IIa and REFLEX extensions

Data were collected on overall and serious adverse events, infusion-related reactions, immunogenicity, infections and serious infections, immunoglobulin levels, cardiovascular events, and malignancies
Care should be exercised in interpreting open-label results due to the inability to minimize bias

Source: van Vollenhoven RF, Emery P, Bingham CO III, et al. Presented at EULAR 2010.

MEASE/COHEN: Retreatment Efficacy Data

Efficacy and Safety of Retreatment With Rituximab in RA: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial

To evaluate efficacy and safety of retreatment in patients with active RA who had had inadequate response to 1 or more TNFi therapies

Phase 3 randomized, double-blind, placebo-controlled ITT analysis

N=559
All enrolled patients received open-label rituximab 2 x 1000 mg on Days 1 and 15
All patients received concurrent methotrexate
Between Weeks 24 and 40, patients not in DAS remission were randomized 2:1 to receive an additional course of rituximab 2 x 1000 mg (n=318) or placebo (n=157)
Baseline characteristics and disease activity were comparable for rituximab and placebo populations
291 rituximab and 134 placebo patients completed 48 weeks

Primary end point: Proportion of retreated patients achieving ACR 20 response at Week 48 compared with baseline
Secondary end points included ACR 50 and ACR 70, changes in DAS28 and EULAR response at 48 weeks compared with baseline, and changes in ACR core set parameters
Additionally patient reported outcomes (PRO) were measured by the SF-36 Health, Survey, HAQ, and FACIT-Fatigue

Source: Mease P, Cohen S, Gaylis N, et al. J Rheumatol. March 1, 2010; doi:10:3899/jrheum.090442

KEYSTONE: Sustained Efficacy in TNFi-IR Patients

Multiple Courses of Rituximab Produce Sustained Efficacy in TNFi-IR Patients With RA

To assess the effect of repeat courses of rituximab in TNFi-IR RA patients responding to their first and second course

Pooled completer analysis of TNFi-IR patients from clinical trials and open-label extensions of REFLEX, DANCER, Keystone, Edwards, MIRROR, SIERRA, and SUNRISE who responded to an initial course of therapy

Depending on the study, patients received retreatment at either 6-month intervals or as needed according to physician evaluation
1324 TNFi-IR received at least one course
146 TNFi-IR received at least 4 courses

All ACR, EULAR, HAQ, and DAS28 responses, together with mean changes, were calculated from the first treatment course baseline
Efficacy data by course were presented as both as observed and "within patient, within visit"
All presented data were observed, with no imputation methods applied
Care should be exercised in interpreting open-label results due to the inability to minimize bias
Data were collected on overall and serious adverse events, infections and serious infection rates over multiple courses

Source: Keystone E, Fleishmann RM, Emery P, et al. Poster presented at ACR 2009.

SIERRA: Immunization responses in RA

Immunization Responses in RA Patients Treated With Rituximab

To evaluate recall response to protein antigens in RA patients receiving rituximab plus methotrexate compared with those receiving methotrexate alone

A multicenter study in patients with active RA receiving a stable dose of methotrexate

N=103
Patients were stratified by age and randomized 2:1 to receive rituximab (1000 mg IV x 2, 2 weeks apart) plus methotrexate for 36 weeks (Active group) vs continuing methotrexate alone for 12 weeks (Control group)
Patients in both groups received tetanus toxoid adsorbed vaccine (Active: Week 24; Control: Day 1), 23-valent pneumococcal polysaccharide vaccine (23VPPV, Active: Week 28; Control: Week 4), neoantigen keyhole limpet hemocyanin (KLH, Active: Weeks 32, 33; Control: Weeks 8,9), and Candida albicans skin test (Active: Day 1, Week 24; Control: Day 1, Week 12)

Anti-tetanus, anti-pneumococcal, and anti-KLH serum IgG levels were measured prior to and 4 weeks following vaccine administration
Delayed-type hypersensitivity (DTH) skin test response was measured 2 to 3 days following placement
Primary outcome was the proportion of patients with at least a fourfold rise in anti-tetanus IgG
Secondary outcome measures were responses to both 23VPPV and KLH, and maintenance of DTH responses to the Candida albicans skin test
The safety of immunization with live viral vaccines following Rituxan therapy has not been studied and vaccination with live vaccines is not recommended in patients receiving Rituxan. Follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of Rituxan.

Source: Bingham C III, Looney RJ, Deodhar A, et al. Arthritis Rheum. 2010;62(1):64-74.

GENOVESE: Safety of biologics post Rituxan

Safety of Biologic Therapies Following Rituximab Treatment in RA Patients

To describe the rate of serious infection events in RA patients treated with rituximab and subsequently receiving a biologic DMARD

Following withdrawal from respective studies, patients entered a safety follow-up (SFU) period during which peripheral B-cell levels were regularly monitored
Patients could receive additional biologics. Data on serious infection events, B-cell levels, and concomitant medications were collected throughout the SFU

RA patients who had received more than one course of rituximab and withdrew from the treatment phase of an international rituximab clinical trial
Patients were drawn from the following studies: REFLEX, SERENE, SUNRISE, MIRROR, SIERRA, DANCER, Edwards (IIa), and the DANCER/IIa and REFLEX extensions

Serious infection events were collected for all patients receiving a biologic DMARD, before and after treatment
Serious infection events were analyzed for all patients receiving a subsequent TNFi, before and after treatment
Limited data are available on the safety of the use of biologic agents or DMARDs other than methotrexate in patients exhibiting peripheral B-cell depletion following treatment with rituximab. Observe patients closely for signs of infection if biologic agents and/or DMARDs are used concomitantly.

Source: Genovese MC, Breedveld FC, Emery P. Presented at EULAR 2010

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