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A Study of Re-Treatment With MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

rituximab [MabThera/Rituxan]

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

adult patients with rheumatoid arthritis who participated in ML19070, and have completed the week 24 visit;
eligible for re-treatment (DAS28 >2.6 after week 24, swollen joint count >=4, tender joint count >=4).

Exclusion Criteria:

patients who have withdrawn from treatment in ML19070 pre-week 16;
patients with a previous response in DAS28 <0.6 to MabThera after week 16;
concurrent treatment with any DMARD except for methotrexate, any TNF alpha inhibitor, or other biologic or investigational agent.

Sites / Locations

Rheumapraxis - Dres. Edmund Edelmann, Gerhard Straeßner und Hans Bloching
Rheuma-Klinikum Bad Bramstedt Klinik fuer Rheumatologie und Immunologie
Campus Charité Mitte Charité Centrum 12. Med.Klinik Abt.Rheumatologie u.Klin.Immunologie
Praxis Dr. Silke Zinke
Immanuel-Krankenhaus; Rheumklinik Berlin Buch
Ev. Waldkrankenhaus Spandau; Klinik für Innere Medizin
Ambulantes Rheumazentrum Dr.med. Helmut Sörensen
Universitätsklinikum Bonn Med. Klinik u.Poliklinik III
HELIOS Seehospital Sahlenburg Abt.Internist.Rheumatologie
Praxis PD Dr. med. Ekkehard Röther
Rheumatologisches MVZ Dresden GmbH, Dres. Holger Schwenke, Reiner Schwenke, Annekatrin Georgi
Med. Versorgungszentrum Kästner + Kästner GbR Ambulantes Rheumazentrum
Universitätsklinikum Erlangen; Medizinische Klinik 3; Rheumatologie und Immunologie
Kliniken Essen; Süd Kath.Krankenhaus St.Josef; Abt. Rheumatologie und Immunologie
Klinik Johann Wolfgang von Goethe Uni; Medizinische Klinik II; Abt. Rheumatologie
Universitätsklinikum Freiburg; Medizinische UNI-Klinik; Abt. Innere Medizin - VI Rheumatologie
Herz-Jesu-Krankenhaus Abt.Geriatrie u. Rheumatologie
Universitätsklinikum Gießen und Marburg GmbH Standort Gießen Medizinische Klinik III
MEDIGREIF Fachkrankenhaus fuer Rheumatologie und Orthopädie; Vogelsang-Gommern
Evangelisches Krankenhaus Hagen-Haspe Rheumaklinik
Universitätsklinikum Halle Klinik u.Poliklinik f.Innere Medizin I
Schön Klinik Hamburg-Eilbek Klinik für Rheumatologie
Medizinische Hochschule Zentrum Innere Medizin Abt.Klinische Immunologie und Rheumatologie
Rheumapraxis PD Dr.med. Bernhard Heilig
UNI-Klinikum Heidelberg Medizinische Klinik Innere Medizin V
Rheumazentrum-Ruhrgebiet, St. Josefs-Krankenhaus; Rheumatologie
Universitaetsklinikum des Saarlandes; medizinische Klinik und Poliklinik; Innere Medizin I
Universitätsklinikum Jena; Klinik für Innere Medizin III
Praxis Dr.med. Ursula Mauß-Etzler
Klinik der Uni zu Köln; Klinik für Innere Medizin
Klinikum der Stadt Ludwigshafen; Medizinische Klinik A
Praxis Andreas Reck
LMU München, Bereich Pettenkoferstr., Medizinische Poliklinik
Praxis Prof. Dr.med. Herbert Kellner
Gemeinschaftspraxis Prof. Dr. med. Klaus Krueger, Guenter Kellerer und Paul Kellerer
Universitätsklinikum Münster Innere Medizin B
Praxis Dr.med. Sylvia Berger
Evang.Krankenhaus Medizinische Klinik
Rheumapraxis an der Hase
Praxis Dr.med. Anett Gräßler
Evangelisches Fachkrankenhaus; Rheumaklinik
Klinikum der Uni Regensburg; Klinik f.Innere Medizin I Abt. Hämatologie und Internistische Onkologie
Praxis Dr.med. Matthias Richter
St.-Josef-Stift Klinik für Rheumatologie
Rheumatologische Schwerpunktpraxis am Feuersee
Johanniter-Krankenhaus im Fläming Treuenbrietzen GmbH; Fachklinik Pneumologie/ Thoraxchirurgie
Universitätsklinikum Tübingen Medizinische UNI-Klinik und Poliklinik Abt. Innere Medizin II
Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.
Praxis Dr.med. Wolf-Dieter Wörth
Medizinisches Zentrum Betriebsteil Marienhöhe Klinik f.Internistische Rheumatologie
Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Hämatologie / Onkologie

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in DAS28 Score at Week 24

DAS28 calculated from the swollen joint count (SJC) and tender joint count (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and Patient Global Asessment of disease activity (participant- rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). A clinically meaningful improvement in DAS28 was defined as an improvement of 1.2 units.

Secondary Outcome Measures

DAS28 Score by Treatment Course and Follow-up (FU) Visit

DAS28 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The DAS28 consists of SJC and TJC measurements, the ESR (measured in mm/hr), and Patient Global Asessment of disease activity (participant-rated arthritis activity assessment) 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 >3.2 to 5.1 = moderate to high disease activity.

Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate' by Treatment Course

DAS28 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline >1.2 with a DAS28 score ≤3.2; moderate responders had a change from baseline >1.2 with a DAS28 score >3.2 to ≤5.1 or a change from baseline >0.6 to ≤1.2 with a DAS28 score ≤5.1.

Percentage of Participants Achieving a Response By EULAR Category and Treatment Course

Response was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline >1.2 with a DAS28 score ≤3.2; moderate responders had a change from baseline >1.2 with a DAS28 score >3.2 to ≤5.1 or a change from baseline >0.6 to ≤1.2 with a DAS28 score ≤5.1; non-responders had a change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with a DAS28 score > 5.1.

Health Assessment Questionnaire - Disability Index (HAQ-DI) Score by Treatment Course

HAQ-DI was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). 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 sub-category items. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The standard disability score was calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered ;total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. The questionnaire was provided in a German translation and was scored based on the instructions from the Stanford University Medical Center.

Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score by Treatment Course

FACIT-F was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The FACIT fatigue scale is based on a 13-item questionnaire to assess the therapy-induced fatigue. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (best) to 52 (worst). The assessment was originally developed for chronic illnesses and is now validated for patients with rheumatoid arthritis (RA). The questionnaire was provided in a German translation.

Short-Form 36 (SF-36) Physical Composite Scores (PCS) by Treatment Course

SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and mental composite t-score (MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.

SF-36 MCS by Treatment Course

SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.

SF-36 Domain Scores by Treatment Course - Physical Functioning

SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.

SF-36 Domain Scores by Treatment Course - Bodily Pain

SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.

SF-36 Domain Scores by Treatment Course - Physical Role Functioning

SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the physical and mental composite t-scores (PCS and MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.

SF-36 Domain Scores by Treatment Course - Emotional Role Functioning

SF-36was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the physical and mental composite t-scores (PCS and MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.

SF-36 Domain Scores by Treatment Course - Emotional Well-Being

SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.

SF-36 Domain Scores by Treatment Course - Social Functioning

SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.

SF-36 Domain Scores by Treatment Course - Vitality

SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.

SF-36 Domain Scores by Treatment Course - General Heath Perceptions

SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.

Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50%, or 70% Improvement (ACR20/ACR50/ACR70) by Treatment Course

ACR response was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). ACR20/50/70 response: ≥20/50/70%, respectively, improvement in SJC or TJC and 20/50/70% improvement in 3 of the following 5 criteria: 1) Physician's Global Assessment of Disease Activity, 2) Patient's Global Assessment of Disease Activity, 3) Patient's Assessment of Pain, 4) participants assessment of functional disability via HAQ-DI, and 5) C-reactive protein (CRP) or ESR at each visit.

Swollen Joint Count

Mean sum of 28 swollen joints was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The 28 joints to be assessed for swelling were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of swollen joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.

Tender Joint Count

Mean sum of 28 tender joints was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The 28 joints to be assessed for tenderness were shoulder, elbow, wrist, MCP joints 1-5, PIP joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.

Physician's Global Assessment of Disease Activity

Physician's Global Assessment of Disease Activity was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070. Physicians were to assess the disease activity on a 100-mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as "no disease activity" (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as "maximum disease activity" (maximum arthritis disease activity).

Patient's Global Assessment of Disease Activity

Patient Global Assessment of Disease Activity was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070. Participants were to assess the disease activity on a 100-mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as "no disease activity" (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as "maximum disease activity" (maximum arthritis disease activity).

Patient's Assessment of Pain

Patient Assessment of Pain was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070. Participants were to assess their current level of pain on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as "no pain" and the right-hand (100 mm) as "unbearable pain".

C-Reactive Protein

CRP measured in milligrams per deciliter (mg/dL) was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070.

Erythrocyte Sedimentation Rate

ESR mean scores measured in mm/hr at was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070.

Rheumatoid Factor (RF)

RF measured in international units per milliliter (IU/mL) was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070.

Full Information

NCT ID

NCT00502840

First Posted

July 17, 2007

Last Updated

July 11, 2017

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT00502840

Brief Title

A Study of Re-Treatment With MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.

Official Title

An Open Label Study to Evaluate the Safety of Re-treatment With MabThera, and Its Effect on Treatment Response, in Patients With Rheumatoid Arthritis Following Inadequate Response to a Single Anti-TNF Agent (Extension Study to ML19070).

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

July 23, 2007 (Actual)

Primary Completion Date

September 20, 2011 (Actual)

Study Completion Date

September 20, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary

This single arm study will evaluate the efficacy and safety of repeated courses of MabThera in patients with active rheumatoid arthritis who have participated in ML19070, and have completed the week 24 visit. Eligible patients (DAS28 >2.6 after week 24), will receive 2 infusions of 1g MabThera (Day 1 and day 15). For all patients in this extension study, up to 3 repeated courses of treatment are allowed. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

193 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

rituximab [MabThera/Rituxan]

Intervention Description

1g iv on days 1 and 15

Primary Outcome Measure Information:

Title

Change From Baseline in DAS28 Score at Week 24

Description

Time Frame

Week 24

Secondary Outcome Measure Information:

Title

DAS28 Score by Treatment Course and Follow-up (FU) Visit

Description

Time Frame

Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12

Title

Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate' by Treatment Course

Description

DAS28 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline >1.2 with a DAS28 score ≤3.2; moderate responders had a change from baseline >1.2 with a DAS28 score >3.2 to ≤5.1 or a change from baseline >0.6 to ≤1.2 with a DAS28 score ≤5.1.

Time Frame

Week 24

Title

Percentage of Participants Achieving a Response By EULAR Category and Treatment Course

Description

Time Frame

Week 24

Title

Health Assessment Questionnaire - Disability Index (HAQ-DI) Score by Treatment Course

Description

Time Frame

Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12

Title

Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score by Treatment Course

Description

Time Frame

Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12

Title

Short-Form 36 (SF-36) Physical Composite Scores (PCS) by Treatment Course

Description

Time Frame

Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12

Title

SF-36 MCS by Treatment Course

Description

SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.

Time Frame

Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12

Title

SF-36 Domain Scores by Treatment Course - Physical Functioning

Description

SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.

Time Frame

Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12

Title

SF-36 Domain Scores by Treatment Course - Bodily Pain

Description

SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.

Time Frame

Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12

Title

SF-36 Domain Scores by Treatment Course - Physical Role Functioning

Description

SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the physical and mental composite t-scores (PCS and MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.

Time Frame

Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12

Title

SF-36 Domain Scores by Treatment Course - Emotional Role Functioning

Description

SF-36was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the physical and mental composite t-scores (PCS and MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.

Time Frame

Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12

Title

SF-36 Domain Scores by Treatment Course - Emotional Well-Being

Description

SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.

Time Frame

Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12

Title

SF-36 Domain Scores by Treatment Course - Social Functioning

Description

SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.

Time Frame

Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12

Title

SF-36 Domain Scores by Treatment Course - Vitality

Description

SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.

Time Frame

Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12

Title

SF-36 Domain Scores by Treatment Course - General Heath Perceptions

Description

SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.

Time Frame

Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12

Title

Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50%, or 70% Improvement (ACR20/ACR50/ACR70) by Treatment Course

Description

Time Frame

24 weeks after each course

Title

Swollen Joint Count

Description

Time Frame

Screening and Week 24

Title

Tender Joint Count

Description

Time Frame

Screening and Week 24

Title

Physician's Global Assessment of Disease Activity

Description

Time Frame

Baseline and Week 24

Title

Patient's Global Assessment of Disease Activity

Description

Time Frame

Baseline and Week 24

Title

Patient's Assessment of Pain

Description

Time Frame

Baseline and Week 24

Title

C-Reactive Protein

Description

Time Frame

Baseline and Week 24

Title

Erythrocyte Sedimentation Rate

Description

Time Frame

Baseline and Week 24

Title

Rheumatoid Factor (RF)

Description

Time Frame

Baseline and Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: adult patients with rheumatoid arthritis who participated in ML19070, and have completed the week 24 visit; eligible for re-treatment (DAS28 >2.6 after week 24, swollen joint count >=4, tender joint count >=4). Exclusion Criteria: patients who have withdrawn from treatment in ML19070 pre-week 16; patients with a previous response in DAS28 <0.6 to MabThera after week 16; concurrent treatment with any DMARD except for methotrexate, any TNF alpha inhibitor, or other biologic or investigational agent.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

Facility Name

Rheumapraxis - Dres. Edmund Edelmann, Gerhard Straeßner und Hans Bloching

City

Bad Aibling

ZIP/Postal Code

83043

Country

Germany

Facility Name

Rheuma-Klinikum Bad Bramstedt Klinik fuer Rheumatologie und Immunologie

City

Bad Bramstedt

ZIP/Postal Code

24576

Country

Germany

Facility Name

Campus Charité Mitte Charité Centrum 12. Med.Klinik Abt.Rheumatologie u.Klin.Immunologie

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Praxis Dr. Silke Zinke

City

Berlin

ZIP/Postal Code

13055

Country

Germany

Facility Name

Immanuel-Krankenhaus; Rheumklinik Berlin Buch

City

Berlin

ZIP/Postal Code

13125

Country

Germany

Facility Name

Ev. Waldkrankenhaus Spandau; Klinik für Innere Medizin

City

Berlin

ZIP/Postal Code

13589

Country

Germany

Facility Name

Ambulantes Rheumazentrum Dr.med. Helmut Sörensen

City

Berlin

ZIP/Postal Code

14163

Country

Germany

Facility Name

Universitätsklinikum Bonn Med. Klinik u.Poliklinik III

City

Bonn

ZIP/Postal Code

53111

Country

Germany

Facility Name

HELIOS Seehospital Sahlenburg Abt.Internist.Rheumatologie

City

Cuxhaven

ZIP/Postal Code

27476

Country

Germany

Facility Name

Praxis PD Dr. med. Ekkehard Röther

City

Donaueschingen

ZIP/Postal Code

78166

Country

Germany

Facility Name

Rheumatologisches MVZ Dresden GmbH, Dres. Holger Schwenke, Reiner Schwenke, Annekatrin Georgi

City

Dresden

ZIP/Postal Code

01109

Country

Germany

Facility Name

Med. Versorgungszentrum Kästner + Kästner GbR Ambulantes Rheumazentrum

City

Erfurt

ZIP/Postal Code

99096

Country

Germany

Facility Name

Universitätsklinikum Erlangen; Medizinische Klinik 3; Rheumatologie und Immunologie

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Kliniken Essen; Süd Kath.Krankenhaus St.Josef; Abt. Rheumatologie und Immunologie

City

Essen

ZIP/Postal Code

45239

Country

Germany

Facility Name

Klinik Johann Wolfgang von Goethe Uni; Medizinische Klinik II; Abt. Rheumatologie

City

Frankfurt Am Main

ZIP/Postal Code

60590

Country

Germany

Facility Name

Universitätsklinikum Freiburg; Medizinische UNI-Klinik; Abt. Innere Medizin - VI Rheumatologie

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Herz-Jesu-Krankenhaus Abt.Geriatrie u. Rheumatologie

City

Fulda

ZIP/Postal Code

36039

Country

Germany

Facility Name

Universitätsklinikum Gießen und Marburg GmbH Standort Gießen Medizinische Klinik III

City

Gießen

ZIP/Postal Code

35392

Country

Germany

Facility Name

MEDIGREIF Fachkrankenhaus fuer Rheumatologie und Orthopädie; Vogelsang-Gommern

City

Gommern

ZIP/Postal Code

39245

Country

Germany

Facility Name

Evangelisches Krankenhaus Hagen-Haspe Rheumaklinik

City

Hagen

ZIP/Postal Code

58135

Country

Germany

Facility Name

Universitätsklinikum Halle Klinik u.Poliklinik f.Innere Medizin I

City

Halle

ZIP/Postal Code

06120

Country

Germany

Facility Name

Schön Klinik Hamburg-Eilbek Klinik für Rheumatologie

City

Hamburg

ZIP/Postal Code

22081

Country

Germany

Facility Name

Medizinische Hochschule Zentrum Innere Medizin Abt.Klinische Immunologie und Rheumatologie

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Rheumapraxis PD Dr.med. Bernhard Heilig

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

UNI-Klinikum Heidelberg Medizinische Klinik Innere Medizin V

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Rheumazentrum-Ruhrgebiet, St. Josefs-Krankenhaus; Rheumatologie

City

Herne

ZIP/Postal Code

44652

Country

Germany

Facility Name

Universitaetsklinikum des Saarlandes; medizinische Klinik und Poliklinik; Innere Medizin I

City

Homburg/Saar

ZIP/Postal Code

66421

Country

Germany

Facility Name

Universitätsklinikum Jena; Klinik für Innere Medizin III

City

Jena

ZIP/Postal Code

07747

Country

Germany

Facility Name

Praxis Dr.med. Ursula Mauß-Etzler

City

Karlsruhe

ZIP/Postal Code

76137

Country

Germany

Facility Name

Klinik der Uni zu Köln; Klinik für Innere Medizin

City

Köln

ZIP/Postal Code

50924

Country

Germany

Facility Name

Klinikum der Stadt Ludwigshafen; Medizinische Klinik A

City

Ludwigshafen

ZIP/Postal Code

67063

Country

Germany

Facility Name

Praxis Andreas Reck

City

Mittelherwigsdorf

ZIP/Postal Code

02763

Country

Germany

Facility Name

LMU München, Bereich Pettenkoferstr., Medizinische Poliklinik

City

Muenchen

ZIP/Postal Code

80336

Country

Germany

Facility Name

Praxis Prof. Dr.med. Herbert Kellner

City

München

ZIP/Postal Code

80935

Country

Germany

Facility Name

Gemeinschaftspraxis Prof. Dr. med. Klaus Krueger, Guenter Kellerer und Paul Kellerer

City

München

ZIP/Postal Code

81541

Country

Germany

Facility Name

Universitätsklinikum Münster Innere Medizin B

City

Münster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Praxis Dr.med. Sylvia Berger

City

Naunhof

ZIP/Postal Code

04683

Country

Germany

Facility Name

Evang.Krankenhaus Medizinische Klinik

City

Oldenburg

ZIP/Postal Code

26122

Country

Germany

Facility Name

Rheumapraxis an der Hase

City

Osnabrück

ZIP/Postal Code

49074

Country

Germany

Facility Name

Praxis Dr.med. Anett Gräßler

City

Pirna

ZIP/Postal Code

01796

Country

Germany

Facility Name

Evangelisches Fachkrankenhaus; Rheumaklinik

City

Ratingen

ZIP/Postal Code

40882

Country

Germany

Facility Name

Klinikum der Uni Regensburg; Klinik f.Innere Medizin I Abt. Hämatologie und Internistische Onkologie

City

Regensburg

ZIP/Postal Code

93053

Country

Germany

Facility Name

Praxis Dr.med. Matthias Richter

City

Rostock

ZIP/Postal Code

18059

Country

Germany

Facility Name

St.-Josef-Stift Klinik für Rheumatologie

City

Sendenhorst

ZIP/Postal Code

48324

Country

Germany

Facility Name

Rheumatologische Schwerpunktpraxis am Feuersee

City

Stuttgart

ZIP/Postal Code

70178

Country

Germany

Facility Name

Johanniter-Krankenhaus im Fläming Treuenbrietzen GmbH; Fachklinik Pneumologie/ Thoraxchirurgie

City

Treuenbrietzen

ZIP/Postal Code

14929

Country

Germany

Facility Name

Universitätsklinikum Tübingen Medizinische UNI-Klinik und Poliklinik Abt. Innere Medizin II

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Praxis Dr.med. Wolf-Dieter Wörth

City

Wiesbaden

ZIP/Postal Code

65189

Country

Germany

Facility Name

Medizinisches Zentrum Betriebsteil Marienhöhe Klinik f.Internistische Rheumatologie

City

Würselen

ZIP/Postal Code

52146

Country

Germany

Facility Name

Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Hämatologie / Onkologie

City

Würzburg

ZIP/Postal Code

97080

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

A Study of Re-Treatment With MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.

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