Uncontrolled Study to Evaluate Efficacy of Tocilizumab in Patients With Moderate or Severe Rheumatoid Arthritis

NCT02087696 | Unknown Phase 4

• 2 other identifiers: FER-TOC-2013-012013-004051-20
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 20

Brief Summary

The purpose of this project is to evaluate the efficacy of Tocilizumab (TCZ) given as monotherapy in patients with active rheumatoid arthritis (RA) according to EULAR response at 24 weeks after treatment initiation. The study design is an intervention study, uncontrolled, multicenter, prospective, 32-weeks, two cohorts of patients with poor compliance or with any contraindication or intolerance to methotrexate. One cohort naive to previous biological therapy and the other one treated previously with a biological treatment.

Conditions

Arthritis, Rheumatoid

Keywords

Arthritis, Rheumatoid; methotrexate; intolerance; poor compliance; contraindication; Tocilizumab; monotherapy

Outcome Measures

Primary Outcomes (1)

• Percentage of patients achieving good or moderate European League Against Rheumatism (EULAR) response.

  To evaluate the efficacy of Tocilizumab monotherapy administered in patients with active rheumatoid arthritis, in terms of percentage of patients achieving good or moderate European League Against Rheumatism (EULAR) response. To be classified as a good response, patients must have a clinically significant change (\> 1.2) in DAS28 index as well as achieving low disease activity. Moderate answer assumes DAS28 index decreases between 0.6 and 1,2, long as it reaches low or moderate disease activity (DAS28 ≤ 5.1), or clinically significant (\> 1.2) in the DAS28 in patients with a moderate or high activity (DAS28\> 3.2) is achieved.

  At 24 weeks of treatment.

Secondary Outcomes (7)

• Changes in the mean of DAS28 index.

  Between baseline and week 24.

• Changes in the mean of Simplex Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI).

  At 24 weeks of treatment.

• Percentage of patients complying American College of Rheumatology (ACR) criteria (ACR20, ACR50 and ACR70).

  At 24 weeks of treatment

• Changes in the mean of DAS28 index into several subgroups.

  between baseline and week 24

• Percentage of patients with a DAS28 index less than or equal to 3.2

  At week 24 of treatment.

Study Arms (2)

Naive biological treatment

OTHER

Rheumatoid arthritis patients with intolerance or poor compliance or contraindication to methotrexate and who have not received previous biological treatment. Tocilizumab dose 8mg/kg administered every 4 weeks for 24 weeks

Drug: Tocilizumab

Previous Biological treatment

OTHER

Rheumatoid arthritis patients with intolerance or poor compliance or contraindication to methotrexate and who have not received more than two previous biological treatments. Tocilizumab dose 8mg/kg administered every 4 weeks for 24 weeks

Drug: Tocilizumab

Interventions

Tocilizumab DRUG

Tocilizumab dose 8mg/kg administered every 4 weeks during 24 weeks.

Also known as: RoActemra

Naive biological treatment; Previous Biological treatment

Eligibility Criteria

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

You may qualify if:

• Patients with ability and willing to provide written informed consent and comply with the requirements of the study protocol.
• years old or older
• DAS28 index greater than 3.2 at baseline.
• Patients receiving outpatient treatment.
• Women of childbearing potential and men with childbearing potential partners may only participate in the study if they use reliable contraception (eg barrier methods \[the patient or her partner\], oral or patch contraceptives, spermicide and barrier method or intrauterine device) during the study period and at least 3 months after receiving the last dose of Tocilizumab.
• In women of childbearing potential the pregnancy test must be negative at the screening visit and at baseline.
• Patients on methotrexate monotherapy or combined treatment with a biological agent, or patients on biological treatment monotherapy, who show or have ever shown intolerance or poor compliance or safety issues with methotrexate.
• Patients judge to be candidates to biological monotherapy by the researcher, without excluding previous use of other disease-modifying antirheumatic drug (DMARDs) different to methotrexate.

You may not qualify if:

• Patients with no peripheral venous access.
• Patients with previous failure to more than two biological treatments.
• Previous treatment with Tocilizumab at any time before the baseline visit.
• Treatment with any other agent on research during the four weeks previous to the screening visit (or equivalent period to its five half-lives) Considering the longest period.
• Previous treatment with cell depletion therapies, including experimental treatments or approved agents, as for examples: CAMPATH, antiCD4, antiCD5, antiCD3, antiCD19 and antiCD20).
• Treatment with intravenous gammaglobulin or plasmapheresis in the 6 months previous to the baseline visit.
• Intra-articular or parenteral corticosteroids within 4 weeks previous to the baseline visit.
• Immunization with a live / attenuated vaccine in the previous 4 weeks to the baseline visit.
• Previous treatment with alkylating agents such as chlorambucil, or full lymphoid irradiation.
• History of severe allergic or anaphylactic reactions to human, humanized or murine, monoclonal antibodies.
• Evidence of serious uncontrolled concomitant disease: cardiovascular, nervous system, lung (including chronic obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus) or gastrointestinal.
• History of diverticulitis, diverticulosis requiring treatment with antibiotics, or chronic lower gastrointestinal ulcer disease, Crohn's disease, ulcerative colitis or any other lower gastrointestinal symptomatic conditions that could predispose to perforations.
• Known active Infections, or a history of known recurring infections: Mycobacterial, fungal, viral or bacterial type (included, but not limited to, tuberculosis, atypical mycobacterial disease, hepatitis B and C, herpes zoster, but excluding nail bed fungal infections).
• Any major episode of infection that required hospitalization or treatment with intravenous antibiotics within 4 weeks previous to the screening visit or oral antibiotics within 2 weeks previous to the screening visit.
• Active tuberculosis requiring treatment in the past year. Latent tuberculosis screening will be perform on all patients according to Spanish Society of Rheumatology/Spanish Agency for Medicines and Health Products (SER/AEMPS) guidelines of the. Patients treated for tuberculosis without recurrence in the past 3 years will not be excluded.

Sponsors & Collaborators

• Spanish Foundation of Rheumatology: lead
• Roche Farma, S.A: collaborator

Study Sites (20)

Hospital Universitario Araba (Sede Txagorritxu)

Vitoria-Gasteiz, Alava, 01009, Spain

ACTIVE NOT RECRUITING

Hospital del la Agencia Valenciana de Salud Vega Baja

Orihuela, Alicante, 03314, Spain

RECRUITING

Hospital Can Misses

Ibiza Town, Balearic Islands, 07800, Spain

RECRUITING

Hospital Universitari Son Espases

Mallorca, Balearic Islands, 07120, Spain

ACTIVE NOT RECRUITING

Hospital Universitari Vall d´Hebron

Barcelona, Barcelona, 08035, Spain

RECRUITING

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

ACTIVE NOT RECRUITING

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008, Spain

ACTIVE NOT RECRUITING

Hospital Universitario Puerta del Mar

Cadiz, Cádiz, 11009, Spain

ACTIVE NOT RECRUITING

Hospital Universitario Reina Sofía

Córdoba, Córdoba, 14004, Spain

RECRUITING

Hospital San Cecilio

Granada, Granada, 18012, Spain

RECRUITING

Hospital Universitario de Guadalajara

Guadalajara, Guadalajara, 19002, Spain

ACTIVE NOT RECRUITING

Complejo hospitalario Universitario de A Coruña

A Coruña, La Coruña, 15006, Spain

RECRUITING

Complejo Asistencial Universitario de León

León, León, 24080, Spain

ACTIVE NOT RECRUITING

Hospital Universitario de La Princesa

Madrid, Madrid, 28006, Spain

RECRUITING

Hospital Civil

Málaga, Málaga, 29009, Spain

RECRUITING

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320, Spain

RECRUITING

Hospital de Sagunto

Sagunto, Valencia, 46520, Spain

RECRUITING

Hospital Clínico Universitario de Valencia

Valencia, Valencia, 46010, Spain

RECRUITING

Hospital Universitario Dr. Peset

Valencia, Valencia, 46017, Spain

RECRUITING

Hospital Galdakao-Usansolo

Galdakao, Vizcaya, 48960, Spain

ACTIVE NOT RECRUITING

Related Publications (31)

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MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

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

Study Officials

• Sara Marsal Barril, MD; PhD

  Hospital Vall d'Hebron

  PRINCIPAL INVESTIGATOR

Central Study Contacts

María Auxiliadora Martín, MD, PhD

CONTACT

0034915767799; mauxiliadora.martin@ser.es

Jesús Tomás Sánchez Costa

CONTACT

003466656 918; jesus.sanchez@ser.es

Study Design

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

Study Record Dates

• First Submitted: March 6, 2014
• First Posted: March 14, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: July 1, 2016
• Last Updated: May 22, 2015

Record last verified: 2015-05

Locations

ES (20)