A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies.

NCT00462345 | Completed Phase 4 Results

• 1 other identifier: ML20934
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

Brief Summary

This single arm study will evaluate the efficacy and safety of MabThera in combination with methotrexate in patients with rheumatoid arthritis who have had an inadequate response to one or more anti-TNF therapies. Patients will receive MabThera 1000mg i.v. on days 1 and 15, and methotrexate (10-25mg/week p.o. or parenteral), together with methylprednisolone 100mg i.v. prior to infusion of MabThera. After week 24, eligible patients may receive re-treatment. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With An American College of Rheumatology 20 Percent (%) Improvement Criteria (ACR20) Response at Week 24

  ACR20 response: ≥20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: Patient Assessment of Pain; Patient Global Assessment of Disease Activity (PtGA); Physician Global Assessment of Disease Activity (PGA); self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ-DI\]); and either C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR).

  Week 24

Secondary Outcomes (18)

• Percentage of Participants With An American College of Rheumatology 50% Improvement Criteria (ACR50) Response at Week 24

  Week 24

• Percentage of Participants With An American College of Rheumatology 70% Improvement Criteria (ACR70) Response at Week 24

  Week 24

• Disease Activity Score Based on 28-Joint Count (DAS-28)

  Baseline and Week 24

• Percentage of Participants With Change in DAS-28 From BL to Week 24 of ≥1.2

  Baseline, Week 24

• Percentage of Participants With DAS Response by European League Against Rheumatism (EULAR) Category at Week 24

  Week 24

Study Arms (1)

Rituximab, Methotrexate

EXPERIMENTAL

Participants received rituximab 1000 milligrams (mg), intravenously (IV), on Day 1 and Day 15. Participants also received methylprednisolone 100 mg, IV, 30 minutes before the infusion of rituximab. Participants also received methotrexate (MTX) 10 to 25 milligrams per week (mg/week), orally (PO) or parenterally, and folate greater than or equal to (≥) 5 mg/week, PO, folate greater than or equal to (≥) 5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone less than or equal to (≤) 10 milligrams per day (mg/day), PO, OR equivalent corticosteroid, OR non-steroidal anti-inflammatory drugs (NSAIDs), PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.

Drug: rituximab; Drug: Methotrexate; Drug: Corticosteroid or NSAID; Dietary Supplement: Folate

Interventions

rituximab DRUG

1000 mg i.v. on Days 1 and 15

Also known as: MabThera, Rituxan

Rituximab, Methotrexate

Methotrexate DRUG

10 to 25 mg/week p.o. or parenteral from Day 1 through Week 24

Rituximab, Methotrexate

Corticosteroid or NSAID DRUG

≤10 mg/day prednisone p.o., or equivalent corticosteroid, or NSAIDs p.o. from Day 1 through Week 24

Rituximab, Methotrexate

Folate DIETARY_SUPPLEMENT

≥5 mg/week, once daily or b.i.d. from Day 1 through Week 24

Rituximab, Methotrexate

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients, 18-80 years of age;
• rheumatoid arthritis for \>=6 months;
• receiving outpatient treatment;
• an inadequate response to at least one anti-TNF therapy;
• stable methotrexate for \>=12 weeks.

You may not qualify if:

• other rheumatic autoimmune disease or inflammatory joint disease;
• previous treatment with MabThera;
• concurrent treatment with any DMARD (apart from methotrexate), anti-TNF alpha therapy, or other biologic agent.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (4)

Unknown Facility

Seoul, 110-744, South Korea

Location

Unknown Facility

Seoul, 133-792, South Korea

Location

Unknown Facility

Seoul, 137701, South Korea

Location

Unknown Facility

Seoul, 138-736, South Korea

Location

Related Publications (1)

• Vieira MC, Zwillich SH, Jansen JP, Smiechowski B, Spurden D, Wallenstein GV. Tofacitinib Versus Biologic Treatments in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors: Results From a Network Meta-analysis. Clin Ther. 2016 Dec;38(12):2628-2641.e5. doi: 10.1016/j.clinthera.2016.11.004. Epub 2016 Nov 24.

  PMID: 27889300 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Rituximab; Methotrexate; Adrenal Cortex Hormones; Anti-Inflammatory Agents, Non-Steroidal; Folic Acid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffman-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2007
• First Posted: April 19, 2007
• Study Start: June 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: November 4, 2014
• Results First Posted: November 4, 2014

Record last verified: 2014-10

Locations

KR (4)