A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate Versus RoActemra/Actemra Monotherapy in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

NCT01399697 | Completed Phase 4 Results

• 1 other identifier: ML27828
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 54

Brief Summary

This randomized, double-blind, parallel-group study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in combination with methotrexate versus RoActemra/Actemra monotherapy in patients with rheumatoid arthritis and an inadequate response to methotrexate. All patients will receive RoActemra/Actemra 8 mg/kg intravenously (iv) every 4 weeks plus oral methotrexate for 16 weeks. Patients achieving low disease activity at Week 16 will be randomized to receive a further 12 weeks of RoActemra/Actemra treatment plus either methotrexate or placebo. Anticipated time on study treatment is 28 weeks.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Change in Disease Activity Score Based on 28-Joint Count (DAS28) From Week 16 to Week 28

  The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (erythrocyte sedimentation rate \[ESR\] in millimeters per hour \[mm/hr\]), and general health status (participant global assessment of disease activity using visual analog scale \[VAS\], range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.

  Baseline, Week 16, and Week 28

Secondary Outcomes (8)

• Percentage of Participants With DAS28 Score Less Than (<) 2.6 at Week 28

  Week 28

• Percentage of Participants With Clinical Disease Activity Index (CDAI) <2.8 at Week 28

  Week 28

• Percentage of Participants With Simplified Disease Activity Index (SDAI) <3.3 at Week 28

  28 weeks

• Change in the Health Assessment Questionnaire Disability Index (HAQ-DI) From Week 16 to Week 28

  Week 16 and Week 28

• Change in the Quality of Life Questionnaire (Short Form-12 [SF-12]) From Week 16 to Week 28 in Mental Health

  Week 16 and Week 28

Study Arms (2)

A

EXPERIMENTAL

Drug: methotrexate; Drug: tocilizumab [RoActemra/Actemra]

B

ACTIVE COMPARATOR

Drug: methotrexate; Drug: placebo; Drug: tocilizumab [RoActemra/Actemra]

Interventions

methotrexate DRUG

orally, Week 1 - 16

A; B

placebo DRUG

methotrexate placebo orally, Week 17-28

B

tocilizumab [RoActemra/Actemra] DRUG

8 mg/kg iv every 4 weeks, 28 weeks

A; B

Eligibility Criteria

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

You may qualify if:

• Adult patients, \>/= 18 years of age
• Active moderate to severe rheumatoid arthritis (DAS28 \>/= 3.2) at baseline
• Currently receiving methotrexate for at least 12 weeks, at a stable oral dose of at least 15 mg/week for at least 6 weeks prior to treatment (Day 1)
• Body weight \< 150 kg
• Oral corticoids must have been at stable dose for at least 25 out of 28 days prior to baseline; maximum dose 10 mg/day

You may not qualify if:

• Pregnant or nursing women
• 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 RA
• Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in Rheumatoid Arthritis
• Prior history of or current inflammatory joint disease other than RA
• Treatment with a biologic agent at any time prior to baseline
• Treatment with traditional DMARDs other than methotrexate within 1 month (for leflunomide 3 months) prior to baseline
• Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
• Previous treatment with RoActemra/Actemra
• History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
• Known active current or history of recurrent infection
• History of or currently active primary or secondary immunodeficiency
• Active tuberculosis requiring treatment within the previous 3 years
• Positive for HIV infection

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (54)

Unknown Facility

Albacete, Albacete, 02006, Spain

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Orihuela, Alicante, 03314, Spain

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Torrevieja, Alicante, 03186, Spain

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Villajoyosa, Alicante, 03570, Spain

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Badajoz, Badajoz, 06080, Spain

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Mérida, Badajoz, 06800, Spain

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Menorca, Balearic Islands, 07701, Spain

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Badalona, Barcelona, 08915, Spain

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Barcelona, Barcelona, 08003, Spain

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Barcelona, Barcelona, 08025, Spain

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Barcelona, Barcelona, 08035, Spain

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Barcelona, Barcelona, 08036, Spain

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Barcelona, Barcelona, 08907, Spain

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Granollers, Barcelona, 08402, Spain

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Terrassa, Barcelona, 08221, Spain

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Cáceres, Caceres, 10310, Spain

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Cadiz, Cadiz, 11009, Spain

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Torrelavega, Cantabria, 39300, Spain

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Villarreal, Castellon, 12540, Spain

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Córdoba, Cordoba, 14004, Spain

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Granada, Granada, 18003, Spain

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Granada, Granada, 18014, Spain

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Guadalajara, Guadalajara, 19002, Spain

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A Coruña, La Coruña, 15006, Spain

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Santiago de Compostela, La Coruña, 15706, Spain

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Las Palmas de Gran Canaria, Las Palmas, 35020, Spain

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León, Leon, 24071, Spain

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Lugo, Lugo, 27004, Spain

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Alcalá de Henares, Madrid, 28805, Spain

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Fuenlabrada, Madrid, 28942, Spain

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Madrid, Madrid, 28007, Spain

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Madrid, Madrid, 28031, Spain

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Madrid, Madrid, 28034, Spain

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Madrid, Madrid, 28040, Spain

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Madrid, Madrid, 28041, Spain

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Madrid, Madrid, 28046, Spain

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Madrid, Madrid, 28905, Spain

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Valdemoro, Madrid, 28342, Spain

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Málaga, Malaga, 29009, Spain

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Cartagena, Murcia, 30203, Spain

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El Palmar, Murcia, 30120, Spain

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Vigo, Pontevedra, 36214, Spain

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Salamanca, Salamanca, 37007, Spain

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Seville, Sevilla, 41009, Spain

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Seville, Sevilla, 41013, Spain

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Santa Cruz de Tenerife, Tenerife, 38010, Spain

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Toledo, Toledo, 45004, Spain

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Manises, Valencia, 46940, Spain

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Valencia, Valencia, 46010, Spain

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Valencia, Valencia, 46017, Spain

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Valenica, Valencia, 46009, Spain

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Barakaldo, Vizcaya, 48903, Spain

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Bilbao, Vizcaya, 48013, Spain

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Galdakao, Vizcaya, 48960, Spain

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Methotrexate; tocilizumab

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)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2011
• First Posted: July 22, 2011
• Study Start: September 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 13, 2015
• Results First Posted: July 13, 2015

Record last verified: 2015-05

Locations

ES (54)