A Study of Two Doses of MRC375 in Moderate to Severe Rheumatoid Arthritis Patients
9 de maio de 2014 atualizado por: Molecular Research Center, Inc.
A 24-week, Phase 2, Double-blind, Placebo-controlled, Randomized Study to Assess the Safety and Efficacy of 2 Doses of MRC375 in Patients With Moderate to Severe Rheumatoid Arthritis
This study will treat moderate to severe rheumatoid arthritis with MRC375 (either 75 mg 3 times a day, 150 mg 3 times a day or placebo 3 times a day)in patients 18 years of age or older that can be currently on low doses of methotrexate or can stop treatment of current RA medications to enter the study.
Safety of MRC375 will also be evaluated.
There are up to 8 clinic visits over 24 weeks.
Visão geral do estudo
Status
Desconhecido
Condições
Intervenção / Tratamento
Descrição detalhada
This is a double-blind, randomized, placebo-controlled study to assess the safety and efficacy of MRC375 at 75 mg or 150 mg with matching placebo (taken tid with meal or light snack) in patients with moderate to severe RA. Patients will be randomized to one of the following study arms for 24 weeks:
- Treatment 1, Placebo: 2 tablets taken tid
- Treatment 2, MRC375: 1 tablet of 75 mg tetracycline HCL plus 1 matching placebo tablet taken tid. Total daily dose = 225 mg.
- Treatment 3, MRC375: 2 tablets of 75 mg tetracycline HCL taken tid. Total daily dose = 450 mg.
Study medication should be taken within 30 minutes of a meal or light snack (either before or after).
Tipo de estudo
Intervencional
Inscrição (Antecipado)
300
Estágio
- Fase 2
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Alabama
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Mobile, Alabama, Estados Unidos, 36608
- Mobile Diagnostic Center Rheumatology
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California
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Long Beach, California, Estados Unidos, 90806
- Valerius Medical Group
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Los Alamitos, California, Estados Unidos, 90720
- Trial Concierge/Pacific Clinical Studies
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Los Angeles, California, Estados Unidos, 90036
- Axis Clinical Trials
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Florida
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Edgewater, Florida, Estados Unidos, 32132
- Riverside Clinical Research
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Miami, Florida, Estados Unidos, 33156
- Global Clinical Professionals
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Palm Harbor, Florida, Estados Unidos, 34684
- The Arthritis Center
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Summerfield, Florida, Estados Unidos, 34491
- Lakeview Medical Research
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Kansas
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Lenexa, Kansas, Estados Unidos, 66219
- Analan Clinical Research
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Kentucky
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Owensboro, Kentucky, Estados Unidos, 42303
- Trial Concierge
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68114
- Quality Clinical Research, Inc.
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89123
- Advanced Biomedical Research of America
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Reno, Nevada, Estados Unidos, 89502
- Arthritis Center of Reno
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North Carolina
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Salisbury, North Carolina, Estados Unidos, 28144
- PMG Research of Salisbury
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Ohio
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Dayton, Ohio, Estados Unidos, 45439
- Providence Health Partners
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Middleburg Heights, Ohio, Estados Unidos, 44130
- Paramount Medical Research & Consulting, LLC
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Virginia
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Williamsburg, Virginia, Estados Unidos, 23185
- The Center for Excellence in Aging and Geriatric Health
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Washington
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Kennewick, Washington, Estados Unidos, 99336
- Apex Clinical Research
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Olympia, Washington, Estados Unidos, 98502
- South Puget Sound Clinical Research Center
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Is 18 years of age
- Is diagnosed with moderate to severe adult onset RA > = 6 months duration, as defined by the 1987 ACR classification criteria
Has moderate to severe RA as defined by:
- ≥4 tender joints/painful (28 joint count) at screening
- ≥4 swollen joints (28 joint count) at screening
- Has a Health Assessment Questionnaire (HAQ) of >0
- Has a physician global assessment (Likert scale) of >0
- Has a patient global assessment of pain (Likert scale) of >0
- Has a patient assessment of pain (Likert scale) of >0
Has stable doses of the following allowable medications during the study, if applicable:
- Stable dose of NSAIDs or other analgesics for at least 2 weeks prior to administration of study drug at regulatory approved doses
- Stable dose of methotrexate 7.5 mg to 25 mg/day once weekly for at least 6 weeks prior to administration of study drug (no changes in dosing regimen for 4 weeks prior to screening)
- Stable dose of hydroxychloroquine either monotherapy or in combination with methotrexate 8 weeks prior to administration of study drug
- Is a non-pregnant, non-lactating female who is postmenopausal, naturally or surgically sterile, or who agree to use effective contraceptive methods throughout the course of the study. Postmenopausal is defined as at least 12 months natural spontaneous amenorrhea
If female of childbearing potential, must agree to use one of the following acceptable birth control methods:
- Surgically sterile (bilateral tubal ligation with surgery at least 6 weeks prior to screening, hysterectomy, or bilateral oophorectomy);
- Intrauterine device (IUD) in place for at least 3 months prior to first dose of study drug;
- Abstinence (not having sexual intercourse);
- Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening and through study completion;
- Stable hormonal contraceptive for at least 3 months prior to study and through study completion
- If female of childbearing potential, has a negative serum hCG pregnancy test at screening
- Is able to swallow whole tablets of orally administered medication
- Is able to understand and provide signed informed consent.
Exclusion Criteria:
- Has been diagnosed with any other inflammatory arthritis (eg, psoriatic arthritis)
- Has a secondary type of arthritis (eg, osteoarthritis) that would interfere with study evaluations
Has taken the following drugs within the timeframe specified below:
- Infliximab, etanercept, adalimumab, abatacept, or other biological therapies (except rituximab) - Within 12 weeks prior to the administration of study drug;
- Rituximab - Within 12 months prior to the administration of study drug;
- Disease-modifying antirheumatic drugs (DMARDs) or other anti-rheumatic therapies not specified above including but not limited to: sulfasalazine, gold, leflunomide, penicillamine, dapsone, azathioprine, 6-mercaptopurine, chlorambucil, cyclophosphamide, cyclosporin, mycophenolate mofetil - Within 12 weeks prior to the administration of study drug;
- Any steroids (glucocorticoids); glucocorticoids must be discontinued for at least 4 weeks prior to administration of study drug. Intraarticular, intramuscular, or intravenous glucocorticoids must not have been given at least 6 weeks prior to administration of study drug.
- Note: Use of probiotics is allowed and is NOT an exclusion criterion.
- Has a uncontrolled symptoms of fibromyalgia with sufficient symptoms requiring treatment (NOTE: patients on a stable dose of treatment for symptoms of fibromyalgia ≥ 4 weeks will be allowed in the study.)
- Has a history of allergic reaction to tetracycline or other related drugs
- Had major surgery or trauma within 28 days prior to screening
- Is concurrently using minocycline or doxycycline (washout of 4 weeks required before the administration of study drug)
- Patients who are on chronic antibiotics or who are on antibiotics for GI infections (such as Clostridium difficile)
- Has clinically significant ECG abnormalities
- Has any clinically significant abnormal laboratory test results found during medical screening including: AST or ALT > 2 x upper limit of normal or serum creatinine > 2.0 mg/dL
- Has clinically significant history or presence of any gastrointestinal pathology (eg, chronic diarrhea, inflammatory bowel disease, acute diverticulitis), irritable bowel syndrome, unresolved gastrointestinal symptoms (eg. diarrhea, vomiting, symptoms of acute diverticulitis), liver or kidney disease, gastric bypass, gastric stapling, use of Lap-Band®, or other conditions known to or which might interfere with the absorption, distribution, metabolism, or excretion of the drug
- Has any historical or active neurological, endocrine, cardiovascular, pulmonary, hematological, psychiatric, or metabolic disease that is considered clinically significant by the Investigator
- Has known history of HIV, hepatitis B or C (patients that have positive hepatitis B serology due to prior vaccination will be allowed in the study)
- Has an active malignancy of any type or history of malignancy. Patients who have a history of a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma (ie. non melanoma skin cancer)and/or localized carcinoma in situ of the cervix are eligible. Patients with a history of other malignancies that have been treated and who have no evidence of recurrence for at least 5 years before study enrollment are also eligible.
- Has difficulty swallowing tablets
- Is ACR Functional Class IV (limited ability to perform usual self-care, vocational, and avocational activities)
- Has known or suspected pregnancy, planned pregnancy, or lactation (for female patients)
- Has clinically significant mental illness (to be determined by the Investigator)
- Has a history in the last 2 years or current evidence of abuse of illicit drugs, prescription medications, or alcohol that, in the opinion of the Investigator, would interfere with adherence to study requirements. Has exposure to any investigational agent within 30 days prior to study entry.
- Was previously enrolled in this study
- Has recent history of bacterial intestinal tract infection (gastroenteritis, colitis, diverticulitis, appendicitis)
- Has a condition the Investigator believes would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results or put the patient at undue risk
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador de Placebo: Placebo
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Matching Placebo 3 times a day for 24 weeks.
Early escape at week 16,20.
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Experimental: MRC375 75 mg
MRC375 (enteric coated Tetracycline) 75 mg 3 times a day
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MRC 375 (enteric coated Tetracycline) 75mg 3 times a day for 24 weeks.
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Experimental: MRC375 150mg
MRC375 (enteric coated Tetracycline) 150mg 3 times a day for 24 weeks.
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MRC375 (enteric coated Tetracycline) 150mg 3 times a day for 24 weeks
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Efficacy evaluated of both doses of MRC375 compared to placebo after 24 weeks of treatment as measured by the rate of achievement of 20% improvement in ACR criteria
Prazo: 24 weeks
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evaluate efficacy of both doses of MRC375 compared to placebo after 24 weeks of treatment, as measured by a rate of achievement of 20% improvement in American College of Rheumatology (ACR) criteria (ACR20) at Week 24
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24 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Safety and tolerability of both doses of MRC375
Prazo: 24 weeks
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evaluate the safety and tolerability of both doses of MRC375 tablets
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24 weeks
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Compare the Efficacy of two doses of MRC375 when compared to a placebo for the change from baseline screening in each of the individual ACR components measuring RA after 24 weeks of treatment
Prazo: 24 weeks
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compare the efficacy of 2 doses of MRC375 tablets (75 mg tid and 150 mg tid) when compared to placebo for the change from baseline screening in each of the individual ACR components measuring rheumatoid arthritis (RA) after 24 weeks of treatment.
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24 weeks
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de novembro de 2011
Conclusão Primária (Antecipado)
1 de julho de 2014
Conclusão do estudo (Antecipado)
1 de julho de 2014
Datas de inscrição no estudo
Enviado pela primeira vez
2 de agosto de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
2 de agosto de 2011
Primeira postagem (Estimativa)
3 de agosto de 2011
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
12 de maio de 2014
Última atualização enviada que atendeu aos critérios de controle de qualidade
9 de maio de 2014
Última verificação
1 de maio de 2014
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- MRC2011-001
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