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Study With Etanercept Focusing on Remission and Predictability of Remission in Real Life Clinical Practice (REACH RA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02202837
Recruitment Status : Completed
First Posted : July 29, 2014
Results First Posted : December 3, 2018
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
Defining Which Remission Criterion at Month 6 Predicts Remission at Month 12 in a Real Life Clinical Practice, in a Cohort of Rheumatoid Arthritis Patients Treated with Etanercept

Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: etanercept

Detailed Description:

The analysis of the primary endpoint will be based on a logistic regression defining the dependent variable as the remission at Month 12 and the 5 independent variables as CDAI, SDAI, DAS28, DAS28 and Ultrasound, and EULAR Boolean definition for clinical practice and clinical studies.

This analysis will be conducted in each arm of the study as well as after a pooling of both patient groups.

In this context it seems reasonable to ensure the completion of the study by a total approximate number of 100 patients (approximately 50 patients per arm). In order to ensure 50 completers in each arm, 70 patients will be recruited at baseline, taking into account a drop out rate of 30% over 1 year period.


Layout table for study information
Study Type : Observational
Actual Enrollment : 157 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Defining Which Remission Criterion At Month 6 Predicts Remission At Month 12 In A Real Life Clinical Practice, In A Cohort Of Rheumatoid Arthritis Patients Treated With Etanercept (Enbrel (Registered))
Actual Study Start Date : August 12, 2014
Actual Primary Completion Date : April 24, 2017
Actual Study Completion Date : April 24, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept

Group/Cohort Intervention/treatment
Etanercept First
Adult patients with RA who receive etanercept as first biologic, according to prevailing Belgian reimbursement criteria
Drug: etanercept
etanercept 1 x 50 mg/week or 2 x 25mg/week

Etanercept second
Adult patients who receive etanercept as second biologic, according to prevailing Belgian reimbursement criteria
Drug: etanercept
etanercept 1 x 50 mg/week or 2 x 25mg/week




Primary Outcome Measures :
  1. Percentage of Participants With Disease Activity Score Based on 28-Joints Count (DAS28) Less Than (<) 2.6 at Month 6 and Maintained Till Month 12 [ Time Frame: Month 6 up to Month 12 ]
    DAS28 was a measure of disease activity in participants with rheumatoid arthritis. DAS28 was calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joints count, C-reactive protein (CRP) (milligrams per liter [mg/L]) or erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) levels and patient global assessment (PGA) of disease activity on a 0-100 mm scale (scores ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicated worst health condition). DAS28 score range from 0 (none) to 9.4 (extreme disease activity). DAS28 [less than or equal to] <=3.2 implied low disease activity and greater than (>) 3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28 less than (<) 2.6 implied remission.

  2. Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3 at Month 6 and Maintained Till Month 12 [ Time Frame: Month 6 up to Month 12 ]
    The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, physician (evaluator) global assessment of disease (EGA) and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition) and CRP (mg/dL). SDAI total score ranged from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. SDAI >3.4 to 11 implied low disease activity, >11 to 26 implied moderate disease activity, >26 implied high disease activity and <=3.3 implied disease remission.

  3. Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 at Month 6 and Maintained Till Month 12 [ Time Frame: Month 6 up to Month 12 ]
    The CDAI was the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition). CDAI total score ranged from 0-76 with higher scores indicating increased disease activity.

  4. Percentage of Participants With Remission at Month 6 and Maintained Till Month 12 Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Studies) Boolean Criterion [ Time Frame: Month 6 up to Month 12 ]
    The ACR/EULAR Boolean-based remission rate measured the severity of disease. A participant was considered as having achieved the Boolean-based ACR/EULAR remission at a visit if all of the following 4 criteria were met at that visit: TJC (in 28 joints) <=1; SJC (in 28 joints) <=1; CRP<=1 mg/dl; PGA<=1 (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition).

  5. Percentage of Participants With Remission at Month 6 and Maintained Till Month 12 Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Practice) Boolean Criterion [ Time Frame: Month 6 up to Month 12 ]
    The ACR/EULAR Boolean-based remission rate measured the severity of disease. A participant was considered as having achieved the Boolean-based ACR/EULAR remission at a visit if all of the following 4 criteria were met at that visit: TJC (in 28 joints) <=1; SJC (in 28 joints) <=1 and PGA<=1 (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition).

  6. Percentage of Participants With Remission Based on Seven-Joint Ultrasound (US7) Measurements at Month 6 and Maintained Till Month 12 [ Time Frame: Month 6 up to Month 12 ]
    A participant was in remission based on US7: if US7 synovitis sum score in grey-scale Ultrasonography (GSUS) =0, Power Doppler Ultrasonography (PDUS) =0 and erosion sum score in GSUS=0. US7 score is musculoskeletal ultrasonography (MKUS) composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. US7 score included MKUS examination of the following joints of the more clinically affected side: wrist, metacarpophalangeal (MCP) II and III, proximal interphalangeal (PIP) II and III, metatarsophalangeal (MTP) II and V. The joints were examined by GSUS and PDUS for synovitis. Synovitis in GSUS and PDUS was analyzed on a scale of 0-3 (GSUS: 0=no synovitis, 3=severe synovitis; higher score=more synovitis); (PDUS: 0=no intraarticular color signal, 3 = >=50% of the intraarticular area filled with color signals). Erosions in GSUS and PDUS were calculated on a binary basis 0 and 1 where 0=no remission and remission=1.

  7. Percentage of Participants With Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) in Combination With Seven-Joint Ultrasound (US7) Measurement at Month 6 and Maintained Till Month 12 [ Time Frame: Month 6 up to Month 12 ]
    Remission based on DAS28 + US7: DAS28 <2.6 and US7 synovitis sum score in GSUS=0, PDUS=0 and US7 erosion sum score in GSUS=0. DAS28: SJC + TJC in 28 joints count + CRP(mg/L) or ESR(mm/hr) levels and PGA on 0-100 mm scale (0 mm [very well] to 100 mm [extremely bad], higher scores indicated worst health condition). U7 Remission: US7 synovitis sum score in GSUS=0, PDUS=0 and erosion sum score in GSUS=0. US7 score is MKUS composite scoring system which combined soft tissue lesions(synovitis) and destructive processes(erosions) in single scoring system. US7 score included MKUS examination of given joints: wrist, MCP II and III, PIP II and III, MTP II and V. Joints were examined by GSUS and PDUS for synovitis on scale of 0-3 (GSUS: 0=no synovitis, 3=severe synovitis; higher score=more synovitis); (PDUS: 0=no intraarticular color signal, 3 = >=50% of intraarticular area filled with color signals). Erosions in GSUS and PDUS were calculated on binary basis 0 (no remission) and 1 (remission).


Secondary Outcome Measures :
  1. Percentage of Participants With Disease Activity Score Based on 28-Joints Count (DAS28) <2.6 at Month 3, 6, 9 and 12 [ Time Frame: Month 3, 6, 9 and 12 ]
    DAS28 was a measure of disease activity in participants with rheumatoid arthritis. DAS28 was calculated from SJC and TJC using 28 joints count, CRP (mg/L) or ESR) (mm/hr) levels and PGA of disease activity on a 0-100 mm scale (scores ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicated worst health condition). DAS28 score range from 0 (none) to 9.4 (extreme disease activity). DAS28 <=3.2 implied low disease activity and > 3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28 <2.6 implied remission.

  2. Percentage of Participants With Simplified Disease Activity Index (SDAI) <=3.3 at Month 3, 6, 9 and 12 [ Time Frame: Month 3, 6, 9 and 12 ]
    The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition) and CRP (mg/dL). SDAI total score ranged from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. SDAI >3.4 to 11 implied low disease activity, >11 to 26 implied moderate disease activity, >26 implied high disease activity and <=3.3 implied disease remission.

  3. Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 at Month 3, 6, 9 and 12 [ Time Frame: Month 3, 6, 9 and 12 ]
    The CDAI was the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition). CDAI total score ranged from 0-76 with higher scores indicating increased disease activity.

  4. Percentage of Participants With Remission Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Studies) Boolean Criterion at Month 3, 6, 9 and 12 [ Time Frame: Month 3, 6, 9 and 12 ]
    The ACR/EULAR Boolean-based remission rate measured the severity of disease. A participant was considered as having achieved the Boolean-based ACR/EULAR remission at a visit if all of the following 4 criteria were met at that visit: TJC (in 28 joints) <=1; SJC (in 28 joints) <=1; CRP<=1 mg/dl; PGA<=1 (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition).

  5. Percentage of Participants With Remission Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Practice) Boolean Criterion at Month 3, 6, 9 and 12 [ Time Frame: Month 3, 6, 9 and 12 ]
    The ACR/EULAR Boolean-based remission rate measured the severity of disease. A participant was considered as having achieved the Boolean-based ACR/EULAR remission at a visit if all of the following 4 criteria were met at that visit: TJC (in 28 joints) <=1; SJC (in 28 joints) <=1 and PGA<=1 (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition).

  6. Percentage of Participants With no Signs of Ultrasound Synovitis (Ultrasound Remission) at Month 6 and 12 [ Time Frame: Month 6 and 12 ]
    A participant was in remission based on US7: if US7 synovitis sum score in GSUS =0, PDUS =0 and erosion sum score in GSUS=0. US7 score is MKUS composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. US7 score included MKUS examination of the following joints of the more clinically affected side: wrist, MCP II and III, PIP II and III, MTP II and V. The joints were examined by GSUS and PDUS for synovitis. Synovitis in GSUS and PDUS was analyzed on a scale of 0-3 (GSUS: 0=no synovitis, 3=severe synovitis; higher score=more synovitis); (PDUS: 0=no intraarticular color signal, 3 = >=50% of the intraarticular area filled with color signals). Erosions in GSUS and PDUS were calculated on a binary basis 0 and 1 where 0=no remission and remission=1.

  7. Percentage of Participants With Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) in Combination With Seven-Joint Ultrasound (US7) Measurement at Month 6 and Month 12 [ Time Frame: Month 6 and 12 ]
    Remission based on DAS28 + US7: DAS28 <2.6 and US7 synovitis sum score in GSUS=0, PDUS=0 and US7 erosion sum score in GSUS=0. DAS28: SJC + TJC in 28 joints count + CRP(mg/L) or ESR(mm/hr) levels and PGA on 0-100 mm scale (0 mm [very well] to 100 mm [extremely bad], higher scores indicated worst health condition). U7 Remission: US7 synovitis sum score in GSUS=0, PDUS=0 and erosion sum score in GSUS=0. US7 score is MKUS composite scoring system which combined soft tissue lesions(synovitis) and destructive processes(erosions) in single scoring system. US7 score included MKUS examination of given joints: wrist, MCP II and III, PIP II and III, MTP II and V. Joints were examined by GSUS and PDUS for synovitis on scale of 0-3 (GSUS: 0=no synovitis, 3=severe synovitis; higher score=more synovitis); (PDUS: 0=no intraarticular color signal, 3 = >=50% of intraarticular area filled with color signals). Erosions in GSUS and PDUS were calculated on binary basis 0 (no remission) and 1 (remission).

  8. Change From Baseline in Disease Activity Score Based on 28-Joints Count (DAS28) at Month 6 and 12 [ Time Frame: Baseline, Month 6 and Month 12 ]
    DAS28 was a measure of disease activity in participants with rheumatoid arthritis. DAS28 was calculated from SJC and TJC using 28 joints count, CRP (mg/L) or ESR (mm/hr) levels and PGA of disease activity on a 0-100 mm scale (scores ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicated worst health condition). DAS28 score range from 0 (none) to 9.4 (extreme disease activity). DAS28 <=3.2 implied low disease activity and > 3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28 <2.6 implied remission.

  9. Change From Baseline in Simplified Disease Activity Index (SDAI) at Month 6 and 12 [ Time Frame: Baseline, Month 6 and Month 12 ]
    The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition) and CRP (mg/dL). SDAI total score ranged from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. SDAI >3.4 to 11 implied low disease activity, >11 to 26 implied moderate disease activity, >26 implied high disease activity and <=3.3 implied disease remission.

  10. Change From Baseline in Clinical Disease Activity Index (CDAI) at Month 6 and 12 [ Time Frame: Baseline, Month 6 and Month 12 ]
    The CDAI was the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition). CDAI total score ranged from 0-76 with higher scores indicating increased disease activity.

  11. Change From Baseline in Seven-Joint Ultrasound (US7) Synovitis Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12 [ Time Frame: Baseline, Month 6 and Month 12 ]
    US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. GSUS is a scoring system use to determine synovitis. The joints were examined by GSUS for synovitis from a dorsal and palmar aspect. The US7 synovitis sum score in GSUS was the sum of the scores for 9 following parts (wrist dorsal, wrist palmar, wrist ulnar, MCP 2 palmar, MCP 3 palmar, PIP 2 palmar, PIP 3 palmar, MTP 2 dorsal, MTP 5 dorsal) on a scale ranging from 0 =no synovitis to 3=severe synovitis. Total US7 GSUS score ranged from 0 (no synovitis) to 27 (severe synovitis), higher score= more synovitis.

  12. Change From Baseline in Seven-Joint Ultrasound (US7) Synovitis Power Doppler Ultrasonography (PDUS) Score at Month 6 and 12 [ Time Frame: Baseline, Month 6 and Month 12 ]
    US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. PDUS assessed the degree of synovial inflammation of the joints of both hands. The joints were examined by PDUS from a dorsal and palmar aspect. The US7 synovitis sum score in PDUS was the sum of the scores of 13 following parts (wrist dorsal, wrist palmar, wrist ulnar, MCP 2 palmar, MCP 2 dorsal, MCP 3 palmar, MCP 3 dorsal, PIP 2 palmar, PIP 2 dorsal, PIP 3 palmar, PIP 3 dorsal, MTP 2 dorsal, MTP 5 dorsal) on a scale ranging from 0=no intraarticular color signal to 3 = >=50% of the intraarticular area filled with color signals. Total US7 PSUS scores ranges from 0=no intraarticular color signal to 39 = >=50% of the intraarticular area filled with color signals; higher scores= more severe disease.

  13. Change From Baseline in Seven-Joint Ultrasound (US7) Tenosynovitis/Paratenonitis Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12 [ Time Frame: Baseline, Month 6 and Month 12 ]
    US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis and tenosynovitis/paratenonitis) and destructive processes (erosions) in a single scoring system. GSUS was a scoring system used to determine the tenosynovitis/paratenonitis. The joints were examined by GSUS from a dorsal and palmar aspect. The US7 tenosynovitis/paratenonitis sum score in GSUS was the sum of the scores for 7 following parts (wrist dorsal, wrist palmar, wrist ulnar, MCP 2 dorsal, MCP I2 palmar, MCP 3 dorsal, MCP 3 palmar) on a scale ranging from 0 =no synovitis to 1=severe synovitis. Total US7 tenosynovitis/paratenonitis GSUS score ranged from 0 (no synovitis) to 7 (severe synovitis), higher score= more synovitis.

  14. Change From Baseline in Seven-Joint Ultrasound (US7) Tenosynovitis/Paratenonitis Power Doppler Ultrasonography (PDUS) Score at Month 6 and 12 [ Time Frame: Baseline, Month 6 and Month 12 ]
    US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis and tenosynovitis/paratenonitis) and destructive processes (erosions) in a single scoring system. PDUS assessed the degree of synovial inflammation of the joints of both hands. The joints were examined by PDUS from a dorsal and palmar aspect. The US7 tenosynovitis/paratenonitis sum score in PDUS was the sum of the scores for 7 following parts (wrist dorsal, wrist palmar, wrist ulnar, MCP 2 dorsal, MCP 2 palmar, MCP 3 dorsal, MCP 3 palmar) on a scale ranging from 0 =no synovitis to 1=severe synovitis. Total US7 tenosynovitis/paratenonitis PDUS score ranged from 0 (no synovitis) to 7 (severe synovitis), higher score= more synovitis.

  15. Change From Baseline in Seven-Joint Ultrasound (US7) Erosion Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12 [ Time Frame: Month 6 and Month 12 ]
    US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. GSUS was a scoring system used to determine the erosions. The joints were examined by GSUS for erosions from a dorsal, palmar/plantar and radial/lateral (only MCP 2 and MTP 5) aspect. The US7 erosion sum score in GSUS was the sum of the 14 following scores (MCP 2 dorsal, MCP 2 palmar, MCP 2 radial, MCP 3 dorsal, MCP 3 palmar, PIP 2 dorsal, PIP 2 palmar, PIP 3 dorsal, PIP 3 palmar, MTP 2 dorsal, MTP 2 plantar, MTP 5 dorsal, MTP 5 plantar and MTP 5 lateral) ranging from 0 to 1. Total score ranged from 0 (no erosions) to 14 (severe erosions), higher score= more erosions. The score was based on measurements made at fingers and toes and were calculated for both left and right sides, the score of the clinically most affected side.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients presenting with moderate-to-severe RA in daily clinical practice
Criteria

Inclusion Criteria:

  1. Patients with active RA who start treatment with etanercept according to the prevailing reimbursement criteria and dosing in line with the SmPC.

    1. First cohort: Etanercept is the first biological product prescribed.
    2. Second cohort: Etanercept is the second biological product prescribed.
  2. Capable of understanding and willing to provide signed and dated written, voluntary informed consent before any protocol-specific procedures are performed.
  3. Eighteen (18) years of age or older at time of consent.

Exclusion Criteria:

1. History of or current psychiatric illness that would interfere with the subject's ability to comply with protocol requirements or to give informed consent.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202837


Locations
Layout table for location information
Belgium
CHU Dinant Godinne
Yvoir, Namur, Belgium, 5530
ASZ Aalst
Aalst, Belgium, 9300
Algemeen Stedelijk Ziekenhuis
Aalst, Belgium, B-9300
Onze Lieve Vrouw Ziekenhuis Aalst
Aalst, Belgium, B-9300
Onze Lieve Vrouw Ziekenhuis
Aalst, Belgium, B-9300
St. Lucas ZH
Assebroeck, Belgium, 8310
St-Lucas Ziekenhuis
Assebroek, Belgium, B-8310
Centre Hospitalier Universitarie Brugmann
Brussels, Belgium, 1020
CHIREC
Brussels, Belgium, 1040
Private Practice
Champion, Belgium, B-5020
AZ Sint Blasius
Dendermonde, Belgium, 9200
AZ Alma
Eeklo, Belgium, 9900
Biomedical Research Institute/ Department of Rheumatology
Genk, Belgium, 3600
Private Practice Rheumatology
Genk, Belgium, 3600
ReumaClinic
Genk, Belgium, 3600
Reumatologie Associatie
Genk, Belgium, 3600
Private Practice
Genk, Belgium, B-3600
Universitair Ziekenhuis Gent
Gent, Belgium, 9000
GHdC
Gilly, Belgium, B-6060
Private Practice
Grand-Manil, Belgium, 5030
AZ Groeninge Campus Sint Maarten
Kortrijk, Belgium
CHU Tivoli
La Louviere, Belgium, 7100
Centre Hospitalier Universitaire Sart Tilman, Department of Rheumatology
Liege, Belgium, 4000
CHU
Liege, Belgium
CHU Sart Tilman/ Department of Rheumatology
Liège, Belgium, 4000
Louisastraat 18
Mechelen, Belgium, 2800
CHU Ambroise Pare
Mons, Belgium, B-7000
Hôpital Saintethérèse
Montigny Sur Sambre, Belgium, 6061
ISPPC de Charleroi
Montigny-le-tilleul, Belgium, 6110
AZ Damiaan
Oostende, Belgium, 8400
Office of Maenaut Kristien
Schoten, Belgium, B-2900
Sint-Andries Ziekenhuis
Tielt, Belgium, B-8700
CH Peltzer-Tourelle
Verviers, Belgium, B-4800
Avenue G Therasse 1
Yvoir, Belgium, 5530
Cliniques Universitaires UCL de Mont-Godinne
Yvoir, Belgium, 5530
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
  Study Documents (Full-Text)

Documents provided by Pfizer:

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02202837     History of Changes
Other Study ID Numbers: B1801378
B1801378 ( Other Identifier: Alias Study Number )
REACH-RA ( Other Identifier: Alias Study Number )
First Posted: July 29, 2014    Key Record Dates
Results First Posted: December 3, 2018
Last Update Posted: December 3, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors