Uncontrolled Study to Evaluate Efficacy of Tocilizumab in Patients With Moderate or Severe Rheumatoid Arthritis
NCT ID: NCT02087696
Last Updated: 2015-05-22
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE4
Total Enrollment
122 participants
Study Classification
INTERVENTIONAL
Study Start Date
2014-05-31
Study Completion Date
2016-07-31
Brief Summary
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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.
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.
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Detailed Description
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Conditions
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Arthritis, Rheumatoid
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Naive biological treatment
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
Group Type
OTHER
Tocilizumab
Intervention Type
DRUG
Tocilizumab dose 8mg/kg administered every 4 weeks during 24 weeks.
Previous Biological treatment
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
Group Type
OTHER
Tocilizumab
Intervention Type
DRUG
Tocilizumab dose 8mg/kg administered every 4 weeks during 24 weeks.
Interventions
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Tocilizumab
Tocilizumab dose 8mg/kg administered every 4 weeks during 24 weeks.
Intervention Type
DRUG
Other Intervention Names
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RoActemra
Eligibility Criteria
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Inclusion Criteria
* Patients with ability and willing to provide written informed consent and comply with the requirements of the study protocol.
* Patients with active moderate or severe rheumatoid arthritis, according to 1987 ACR criteria, diagnosed at least 6 months before inclusion.
* 18 years old or older
* DAS28 index greater than 3.2 at baseline.
* If patients are receiving corticosteroid the dose will have to be ≤ 10 mg of prednisone (or equivalent) and the patient must have been stable for at least one month previous to initiating treatment with Tocilizumab (day 1). Patients may have been treated with nonsteroidal antiinflammatory drug (NSAIDs) at stable doses during the previous month to inclusion.
* 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.
* Patients with active moderate or severe rheumatoid arthritis, according to 1987 ACR criteria, diagnosed at least 6 months before inclusion.
* 18 years old or older
* DAS28 index greater than 3.2 at baseline.
* If patients are receiving corticosteroid the dose will have to be ≤ 10 mg of prednisone (or equivalent) and the patient must have been stable for at least one month previous to initiating treatment with Tocilizumab (day 1). Patients may have been treated with nonsteroidal antiinflammatory drug (NSAIDs) at stable doses during the previous month to inclusion.
* 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.
Exclusion Criteria
* 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.
* Ongoing liver disease as determined by the principal investigator.
* Evidence of active malignancy, malignancies diagnosed in the previous 10 years (including solid and hematologic tumors, except basal cell carcinoma and squamous cell skin or removed and cured in situ cervix carcinoma), or breast cancer diagnosed in the previous 20 years.
* Pregnant or breastfeeding women.
* Patients with reproductive potential who are unwilling to use effective contraception.
* History of alcoholism, drug abuse or addiction in the previous year to the screening visit.
* Neuropathies or other painful conditions that may interfere with pain assessment.
* Serum creatinine \>1,4 mg/dl (124 mol/l) in women and \>1.6 mg/dl (141 mol/l) in men.
* Alanine aminotransferase or aspartate aminotransferase \> 1.5 times the upper limit of normal.
* Total bilirubin greater than the upper limit of normal.
* Platelet count minor than 100 x 10\^9/l (100.000/mm3).
* Hemoglobin minor than 85 g/L (\<8,5 g/dL, 5,3 mmol/L).
* Leukocytes minor than 3,0 x 10\^9/L (3000/mm3).
* Neutrophils, absolute value minor than 2,0 x 10\^9/L (2000/mm3).
* Lymphocytes, absolute value minor than 0,5 x 10\^9 /L (500/mm3).
* 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.
* Ongoing liver disease as determined by the principal investigator.
* Evidence of active malignancy, malignancies diagnosed in the previous 10 years (including solid and hematologic tumors, except basal cell carcinoma and squamous cell skin or removed and cured in situ cervix carcinoma), or breast cancer diagnosed in the previous 20 years.
* Pregnant or breastfeeding women.
* Patients with reproductive potential who are unwilling to use effective contraception.
* History of alcoholism, drug abuse or addiction in the previous year to the screening visit.
* Neuropathies or other painful conditions that may interfere with pain assessment.
* Serum creatinine \>1,4 mg/dl (124 mol/l) in women and \>1.6 mg/dl (141 mol/l) in men.
* Alanine aminotransferase or aspartate aminotransferase \> 1.5 times the upper limit of normal.
* Total bilirubin greater than the upper limit of normal.
* Platelet count minor than 100 x 10\^9/l (100.000/mm3).
* Hemoglobin minor than 85 g/L (\<8,5 g/dL, 5,3 mmol/L).
* Leukocytes minor than 3,0 x 10\^9/L (3000/mm3).
* Neutrophils, absolute value minor than 2,0 x 10\^9/L (2000/mm3).
* Lymphocytes, absolute value minor than 0,5 x 10\^9 /L (500/mm3).
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Roche Farma, S.A
INDUSTRY
Sponsor Role
collaborator
Spanish Foundation of Rheumatology
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Sara Marsal Barril, MD; PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Vall d'Hebron
Locations
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Hospital Universitario Araba (Sede Txagorritxu)
Vitoria-Gasteiz, Alava, Spain
Site Status
ACTIVE_NOT_RECRUITING
Hospital del la Agencia Valenciana de Salud Vega Baja
Orihuela, Alicante, Spain
Site Status
RECRUITING
Hospital Can Misses
Ibiza Town, Balearic Islands, Spain
Site Status
RECRUITING
Hospital Universitari Son Espases
Mallorca, Balearic Islands, Spain
Site Status
ACTIVE_NOT_RECRUITING
Hospital Universitari Vall d´Hebron
Barcelona, Barcelona, Spain
Site Status
RECRUITING
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Site Status
ACTIVE_NOT_RECRUITING
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Site Status
ACTIVE_NOT_RECRUITING
Hospital Universitario Puerta del Mar
Cadiz, Cádiz, Spain
Site Status
ACTIVE_NOT_RECRUITING
Hospital Universitario Reina Sofía
Córdoba, Córdoba, Spain
Site Status
RECRUITING
Hospital San Cecilio
Granada, Granada, Spain
Site Status
RECRUITING
Hospital Universitario de Guadalajara
Guadalajara, Guadalajara, Spain
Site Status
ACTIVE_NOT_RECRUITING
Complejo hospitalario Universitario de A Coruña
A Coruña, La Coruña, Spain
Site Status
RECRUITING
Complejo Asistencial Universitario de León
León, León, Spain
Site Status
ACTIVE_NOT_RECRUITING
Hospital Universitario de La Princesa
Madrid, Madrid, Spain
Site Status
RECRUITING
Hospital Civil
Málaga, Málaga, Spain
Site Status
RECRUITING
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain
Site Status
RECRUITING
Hospital de Sagunto
Sagunto, Valencia, Spain
Site Status
RECRUITING
Hospital Clínico Universitario de Valencia
Valencia, Valencia, Spain
Site Status
RECRUITING
Hospital Universitario Dr. Peset
Valencia, Valencia, Spain
Site Status
RECRUITING
Hospital Galdakao-Usansolo
Galdakao, Vizcaya, Spain
Site Status
ACTIVE_NOT_RECRUITING
Countries
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Spain
Central Contacts
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References
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Carmona L, Villaverde V, Hernandez-Garcia C, Ballina J, Gabriel R, Laffon A; EPISER Study Group. The prevalence of rheumatoid arthritis in the general population of Spain. Rheumatology (Oxford). 2002 Jan;41(1):88-95. doi: 10.1093/rheumatology/41.1.88.
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Carmona L, Ballina J, Gabriel R, Laffon A; EPISER Study Group. The burden of musculoskeletal diseases in the general population of Spain: results from a national survey. Ann Rheum Dis. 2001 Nov;60(11):1040-5. doi: 10.1136/ard.60.11.1040.
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Askling J, Fored CM, Brandt L, Baecklund E, Bertilsson L, Feltelius N, Coster L, Geborek P, Jacobsson LT, Lindblad S, Lysholm J, Rantapaa-Dahlqvist S, Saxne T, van Vollenhoven RF, Klareskog L. Time-dependent increase in risk of hospitalisation with infection among Swedish RA patients treated with TNF antagonists. Ann Rheum Dis. 2007 Oct;66(10):1339-44. doi: 10.1136/ard.2006.062760. Epub 2007 Jan 29.
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Heiberg MS, Koldingsnes W, Mikkelsen K, Rodevand E, Kaufmann C, Mowinckel P, Kvien TK. The comparative one-year performance of anti-tumor necrosis factor alpha drugs in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: results from a longitudinal, observational, multicenter study. Arthritis Rheum. 2008 Feb 15;59(2):234-40. doi: 10.1002/art.23333.
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Listing J, Strangfeld A, Rau R, Kekow J, Gromnica-Ihle E, Klopsch T, Demary W, Burmester GR, Zink A. Clinical and functional remission: even though biologics are superior to conventional DMARDs overall success rates remain low--results from RABBIT, the German biologics register. Arthritis Res Ther. 2006;8(3):R66. doi: 10.1186/ar1933. Epub 2006 Apr 5.
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Soliman MM, Ashcroft DM, Watson KD, Lunt M, Symmons DP, Hyrich KL; British Society for Rheumatology Biologics Register. Impact of concomitant use of DMARDs on the persistence with anti-TNF therapies in patients with rheumatoid arthritis: results from the British Society for Rheumatology Biologics Register. Ann Rheum Dis. 2011 Apr;70(4):583-9. doi: 10.1136/ard.2010.139774. Epub 2011 Feb 17.
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Yazici Y, Shi N, John A. Utilization of biologic agents in rheumatoid arthritis in the United States: analysis of prescribing patterns in 16,752 newly diagnosed patients and patients new to biologic therapy. Bull NYU Hosp Jt Dis. 2008;66(2):77-85.
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Dougados M, Kissel K, Sheeran T, Tak PP, Conaghan PG, Mola EM, Schett G, Amital H, Navarro-Sarabia F, Hou A, Bernasconi C, Huizinga TW. Adding tocilizumab or switching to tocilizumab monotherapy in methotrexate inadequate responders: 24-week symptomatic and structural results of a 2-year randomised controlled strategy trial in rheumatoid arthritis (ACT-RAY). Ann Rheum Dis. 2013 Jan;72(1):43-50. doi: 10.1136/annrheumdis-2011-201282. Epub 2012 May 5.
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Jones G, Sebba A, Gu J, Lowenstein MB, Calvo A, Gomez-Reino JJ, Siri DA, Tomsic M, Alecock E, Woodworth T, Genovese MC. Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: the AMBITION study. Ann Rheum Dis. 2010 Jan;69(1):88-96. doi: 10.1136/ard.2008.105197.
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BACKGROUND
Bykerk VP, Ostor AJ, Alvaro-Gracia J, Pavelka K, Ivorra JA, Graninger W, Bensen W, Nurmohamed MT, Krause A, Bernasconi C, Stancati A, Sibilia J. Tocilizumab in patients with active rheumatoid arthritis and inadequate responses to DMARDs and/or TNF inhibitors: a large, open-label study close to clinical practice. Ann Rheum Dis. 2012 Dec;71(12):1950-4. doi: 10.1136/annrheumdis-2011-201087. Epub 2012 May 21.
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BACKGROUND
Emery P, Keystone E, Tony HP, Cantagrel A, van Vollenhoven R, Sanchez A, Alecock E, Lee J, Kremer J. IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-tumour necrosis factor biologicals: results from a 24-week multicentre randomised placebo-controlled trial. Ann Rheum Dis. 2008 Nov;67(11):1516-23. doi: 10.1136/ard.2008.092932. Epub 2008 Jul 14.
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BACKGROUND
Carmona L, Gomez-Reino JJ, Rodriguez-Valverde V, Montero D, Pascual-Gomez E, Mola EM, Carreno L, Figueroa M; BIOBADASER Group. Effectiveness of recommendations to prevent reactivation of latent tuberculosis infection in patients treated with tumor necrosis factor antagonists. Arthritis Rheum. 2005 Jun;52(6):1766-72. doi: 10.1002/art.21043.
Reference Type
BACKGROUND
Other Identifiers
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2013-004051-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
FER-TOC-2013-01
Identifier Type: -
Identifier Source: org_study_id
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COMPLETED
PHASE3
A Study of Tocilizumab as Monotherapy or in Combination With DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis
NCT01089023
COMPLETED
PHASE4
A Study of Tocilizumab and Methotrexate Treatment Strategies (Adding Tocilizumab to Methotrexate Versus Switching to Tocilizumab) in Patients With Active Rheumatoid Arthritis With Inadequate Response to Prior Methotrexate Treatment
NCT00810199
COMPLETED
PHASE3
A Long-Term Extension Study to WA19926 (NCT01007435) of Tocilizumab in Participants With Early, Moderate to Severe Rheumatoid Arthritis
NCT01665430
TERMINATED
PHASE3
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
PHASE4
An Exploratory Study of Tocilizumab in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Current Non-Biologic DMARDs and/or Anti-TNF Therapy.
NCT00750880
COMPLETED
PHASE3
A Study of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis
NCT00531817
COMPLETED
PHASE3
An Open-label Study With Tocilizumab in Patients With Rheumatoid Arthritis in a Local Environment
NCT01254331
COMPLETED
PHASE3
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis
NCT01245439
COMPLETED
PHASE3
A Study of Tocilizumab With or Without Methotrexate in Patients With Rheumatoid Arthritis.
NCT01010503
COMPLETED
PHASE4
A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis
NCT01232569
COMPLETED
PHASE3
Regulation of the Immune System in Response to the Treatment With Tocilizumab in Rheumatoid Arthritis Patients
NCT01633346
COMPLETED
An Observational Study of RoActemra/Actemra in Patients With Moderate to Severe Rheumatoid Arthritis
NCT01375478
COMPLETED
A Study of RoActemra/Actemra (Tocilizumab) With or Without Methotrexate in Patients With Mild to Moderate Rheumatoid Arthritis With an Inadequate Response to Methotrexate
NCT01587989
COMPLETED
PHASE3
A Study of Tocilizumab (RoActemra/Actemra) Versus Adalimumab in Patients With Rheumatoid Arthritis
NCT01119859
COMPLETED
PHASE4
A Study to Assess the Safety and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis
NCT00109408
COMPLETED
PHASE3
A Non-Interventional Study in Patients With Rheumatoid Arthritis Who Are Treated With RoActemra/Actemra (Tocilizumab)
NCT01893255
WITHDRAWN
Efficacy and Safety of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis
NCT01211834
COMPLETED
PHASE3
A Study of Tocilizumab Added to DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to DMARDs.
NCT00996203
COMPLETED
PHASE4
Abatacept vs Tocilizumab for the Treatment of RA in TNF Alpha Inhibitor Inadequate Responders
NCT03227419
UNKNOWN
PHASE4