A Study of RoActemra/Actemra (Tocilizumab) in Combination With DMARDs Versus Current Best Practice DMARD Therapy in Patients With Rheumatoid Arthritis

NCT01251120 | Terminated Phase 4 Results

• 1 other identifier: ML25346
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 6

Brief Summary

This randomized, open-label, parallel-group study will assess the effect on disease remission of RoActemra/Actemra (tocilizumab) in combination with disease-modifying antirheumatic drugs (DMARDs) versus current best practice non-biologic DMARD therapy in patients with moderate-to-severe active rheumatoid arthritis. Patients who are randomly assigned to the RoActemra/Actemra treatment group will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks. The anticipated time on study treatment is 12 months.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Disease Remission at Month 12 Assessed Using the Disease Activity Score Based on 28-Joint Count (DAS28)

  The DAS28 is a combined index for measuring disease activity in Rheumatoid Arthritis (RA). The index includes swollen and tender joint counts (SJC and TJC), acute phase response, and general health status. For this study Erythrocyte sedimentation Rate (ESR) was to be used to calculate DAS28 score. The DAS28, which uses a 28 joint count, is derived from the original DAS which includes a 44 swollen joint count. The DAS28 has been validated in RA. The index is calculated using the following formula: DAS28 equals (=) 0.56 times (×) square root of √(TJC) plus (+) 0.28 × √(SJC) + 0.70 × ln(ESR) + 0.014 × GH Where, TJC28 = tender joint count on 28 joints, SJC28 = swollen joint count on 28 joints, ln = natural log, ESR measured as millimeters per hour (mm/hr), and GH = general health, which is participant's global assessment of disease activity (100-mm Visual Analog Scale \[VAS\]). DAS28 less than/equal to (≤) 2.6 defined remission.

  Month 12

Secondary Outcomes (7)

• Number of Hours Absent From Work

  Baseline and 6 and 12 months

• Percentage of Participants Achieving Disease Remission at Month 6 Assessed Using DAS28

  Month 6

• Percentage of Participants Achieving Responses According to American College of Rheumatology (ACR) Criteria

  Months 6 and 12

• Percentage of Participants Achieving Remission at Months 6 and 12 Assessed Using Clinical Activity Disease Index (CDAI)

  Months 6 and 12

• Change From Baseline to Months 6 and 12 in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT F) Scores

  Baseline and Months 6 and 12

Study Arms (2)

1

EXPERIMENTAL

Drug: tocilizumab [RoActemra/Actemra]

2

ACTIVE COMPARATOR

Drug: DMARD

Interventions

tocilizumab [RoActemra/Actemra] DRUG

8 mg/kg intravenously every 4 weeks plus background DMARDs (including methotrexate)

1

DMARD DRUG

Non-biologic DMARDs (including methotrexate) according to current best practice

2

Eligibility Criteria

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

You may qualify if:

• Adult patients, over the age of 18 years
• Diagnosis of moderate-to-severe active early rheumatoid arthritis (RA) of less than 2 years duration
• DAS28 \>3.2
• Swollen joint count (SJC) \>/=6 (66 joint count), and tender joint count (TJC) \>/=6 (68 joint count)
• Patients who have received DMARDs (including methotrexate) for 3-7 months

You may not qualify if:

• Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after baseline
• Rheumatic autoimmune disease other than rheumatoid arthritis (secondary Sjögrens syndrome or nodulosis with RA is permitted)
• Functional class III or IV as defined by ACR Classification of Functional Status in Rheumatoid Arthritis
• Prior history of or current inflammatory joint disease other than RA

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (6)

Unknown Facility

Hämeenlinna, 13530, Finland

Location

Unknown Facility

Helsinki, 00029, Finland

Location

Unknown Facility

Jyväskylä, 40620, Finland

Location

Unknown Facility

Kuopio, 70101, Finland

Location

Unknown Facility

Riihimäki, 11101, Finland

Location

Unknown Facility

Rovaniemi, 96101, Finland

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumab; Antirheumatic Agents

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)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann- LaRoche

genentech@druginfo.com

1-800-821-8590

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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2010
• First Posted: December 1, 2010
• Study Start: November 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: November 11, 2014
• Results First Posted: November 11, 2014

Record last verified: 2014-11

Locations

FI (6)