Remission Induction in Very Early Rheumatoid Arthritis

NCT00523692

Last updated date
Study Location
University Hopsital Birmingham NHS Foundation Trust
Birmingham, West Midlands, B15 2TH, United Kingdom
Contact
00 44 1214143837

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Age over 18 years

- Synovial swelling of at least 1 joint confirmed by clinical assessment

- Duration of symptoms attributable to inflammatory joint disease (pain, swelling or early morning stiffness of >1 hour) of < 12 weeks.

- Seropositivity for RF and anti-CCP Ab

- Women of childbearing potential or men capable of fathering children must be using adequate birth control measures (eg, abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, surgical sterilization) during the study.

- Female subjects of childbearing potential must test negative for pregnancy

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Previous history of inflammatory arthritis.


- Previous use of DMARDs or anti-TNF-agents.


- Any current inflammatory condition with signs or symptoms that might confound the
diagnosis (e.g. connective tissue disorders).


- Clinical evidence of latent or active granulomatous infection, including TB,
histoplasmosis, or coccidioidomycosis, prior to study entry.


- Administration, or expected administration, of any live virus or bacterial vaccination
within 3 months before the first administration of study agent, or during the trial.


- A history of an infected joint prosthesis, or administration of antibiotics for a
suspected infection of a joint prosthesis, if that prosthesis has not been removed or
replaced.


- Known infection with HIV, hepatitis B, or hepatitis C.


- A serious infection that in the opinion of the investigator precludes receipt of a TNF
blocking agent.


- Serious and uncontrolled co-existing disease that in the opinion of the investigator
preclude the use of TNF-blocking medication, methotrexate or depomedrone (including
pulmonary disease on chest radiograph, congestive cardiac failure (NYHA grade 3 or 4),
history of demyelinating disease such as multiple sclerosis or optic neuritis).


- Bleeding disorder of the use of anti-coagulants


- Any known malignancy or a history of malignancy within the previous 5 years (with the
exception of a basal cell carcinoma that has been treated with no evidence of
recurrence).


- Any other contraindication to etanercept, methotrexate or parenteral depomedrone.


- Patients will also be excluded with the following laboratory results: haemoglobin <8.5
gm/dl, total white cell count <3.5 x 109/litre, serum transaminase value more than
twice the upper limit of normal, and serum creatinine >150 micromoles/litre.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Remission Induction in Very Early Rheumatoid Arthritis
Official Title  ICMJE Remission Induction in Very Early Rheumatoid Arthritis: a Comparison of Etanercept Plus Methotrexate Plus Steroid With Standard Therapy
Brief Summary Rheumatoid arthritis (RA) is a debilitating chronic immune mediated inflammatory disease which affects 1% of the European population. RA is associated with significant joint damage, disability and an enhanced mortality. Current treatment strategies target patients once synovitis has been present for several months and it is clear that the patient has developed persistent disease. After the first 3 months of symptoms, we and others have shown that the persistence of chronic inflammation in the rheumatoid synovium is driven by hyperplastic stromal tissue which inhibits leukocyte apoptosis leading to the accumulation of inflammatory cells in the joint. Therapies at this stage of disease, with conventional disease modifying anti-rheumatic drugs (DMARDs) as well as drugs targeting TNF-alpha reduce disease activity but are unable to cure RA. We have now identified that the very early phase of synovitis in patients destined to develop RA (within the first 12 weeks of symptoms) represents a pathologically distinct phase of disease. This suggests that late disease is not just more of early disease and gives, for the first time, a clear rationale for very early intervention. Building on these recent observations, we propose to test the hypothesis that the disease processes in the very early stages of RA are fundamentally different to those in established chronic disease. This will be done by assessing whether treatment during this phase with the well-established gold standard modality of anti-TNF-alpha therapy and methotrexate can permanently switch off inflammation, preventing the development of RA and thereby effecting a cure of the disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: Etanercept, methotrexate and depomedrone
    Etanercept (50mg weekly; subcutaneous) Methotrexate (7.5-25mg weekly; oral) Depomedrone (up to 120mg; intraarticular / intramuscular)
  • Drug: depemedrone
    depomedrone (up to 120mg im/ia) methotrexate (added after symptoms have been present for 12 weeks)
Study Arms  ICMJE
  • Experimental: 1
    Intensive therapy
    Intervention: Drug: Etanercept, methotrexate and depomedrone
  • Active Comparator: 2
    Standard therapy
    Intervention: Drug: depemedrone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 30, 2007)
20
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age over 18 years
  • Synovial swelling of at least 1 joint confirmed by clinical assessment
  • Duration of symptoms attributable to inflammatory joint disease (pain, swelling or early morning stiffness of >1 hour) of < 12 weeks.
  • Seropositivity for RF and anti-CCP Ab
  • Women of childbearing potential or men capable of fathering children must be using adequate birth control measures (eg, abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, surgical sterilization) during the study.
  • Female subjects of childbearing potential must test negative for pregnancy

Exclusion Criteria:

  • Previous history of inflammatory arthritis.
  • Previous use of DMARDs or anti-TNF-agents.
  • Any current inflammatory condition with signs or symptoms that might confound the diagnosis (e.g. connective tissue disorders).
  • Clinical evidence of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to study entry.
  • Administration, or expected administration, of any live virus or bacterial vaccination within 3 months before the first administration of study agent, or during the trial.
  • A history of an infected joint prosthesis, or administration of antibiotics for a suspected infection of a joint prosthesis, if that prosthesis has not been removed or replaced.
  • Known infection with HIV, hepatitis B, or hepatitis C.
  • A serious infection that in the opinion of the investigator precludes receipt of a TNF blocking agent.
  • Serious and uncontrolled co-existing disease that in the opinion of the investigator preclude the use of TNF-blocking medication, methotrexate or depomedrone (including pulmonary disease on chest radiograph, congestive cardiac failure (NYHA grade 3 or 4), history of demyelinating disease such as multiple sclerosis or optic neuritis).
  • Bleeding disorder of the use of anti-coagulants
  • Any known malignancy or a history of malignancy within the previous 5 years (with the exception of a basal cell carcinoma that has been treated with no evidence of recurrence).
  • Any other contraindication to etanercept, methotrexate or parenteral depomedrone.
  • Patients will also be excluded with the following laboratory results: haemoglobin <8.5 gm/dl, total white cell count <3.5 x 109/litre, serum transaminase value more than twice the upper limit of normal, and serum creatinine >150 micromoles/litre.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00523692
Other Study ID Numbers  ICMJE RRK2939
REC reference 06/Q2404/95
EudraCT number 2006-001428-38
CTA number 16719/0201/001-0001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University Hospital Birmingham
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator:Karim Raza, MRCP PhDUniversity of Birmingham
Study Director:Christopher D Buckley, FRCP PhDUniversity of Birmingham
PRS Account University Hospital Birmingham
Verification Date August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP