An Observational Study in Clinical Practice Management of Patients With Biological Drugs in Monotherapy

NCT01664117 | Completed Results

• 2 other identifiers: ML28356ROC-BIO-2011-01
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 41

Brief Summary

This observational multicenter study will evaluate the management of disease and safety in clinical practice in patients with moderate to severe rheumatoid arthritis receiving any biological therapies in monotherapy.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (23)

• Number of Participants With Level of Education Completed

  Level of education completed is a component of socio-demographic characteristics. It is recorded as cannot read, no formal education, primary education or equivalent, general secondary education, vocational education, and higher education or equivalent. Data were collected at study entry (Single visit study)

  At Visit 1 (Single visit study)

• Number of Participants With Smoking Habits

  Smoking habits is a component of socio-demographic characteristics. Participants' smoking status is recorded as non-smoker, smoker, and ex-smoker at Visit 1.

  At Visit 1

• Smoking-habit for Smokers or Ex-smokers (Packs in Years)

  Smoking-habit included number of pack per years is reported.

  At Visit 1

• Smoking-habit or Smokers or Ex-smokers (Smoking/Quit Smoking )

  Smoking-habit included years of smoking/quit smoking is reported for participants.

  At Visit 1

• Mean Time of Onset of Rheumatoid Arthritis

  Onset of rheumatoid arthritis is a component of clinical characteristics.

  At Visit 1

• Number of Participants With Family History of Rheumatoid Arthritis

  Family history is a component of clinical characteristics. Participants who had a family history of rheumatoid arthritis is recorded as yes/no. Also, family history related to parents, siblings, aunts and uncles, grandparents, or other is recorded.

  At Visit 1

• Number of Participants With Co-morbidities

  Co-morbidity is a component of clinical characteristics It included stroke, heart failure (grades I, II, III or IV), ischemic heart disease, hypertension, dyslipidemia, osteoporosis, interstitial lung disease, chronic obstructive pulmonary disease (COPD), depression, diabetes mellitus, liver disease, serious infections, tuberculosis, hematological malignancies, solid tumors and others. Participants were assessed into categories with associated co-morbidities as yes and no.

  At Visit 1

• Number of Participants With Extra-articular Manifestations at Visit 1

  Extra-articular manifestations (EAMs) are a component of of clinical characteristics EAMs are symptoms and diseases that occur in parts of the body other than joints. These included the presence of amyloidosis (rare disease that results from the buildup of misfolded proteins), anemia (deficiency of red cells in the blood), heart complications, lung complications, rheumatoid nodules (local swelling), felty's syndrome (presence of rheumatoid arthritis, an enlarged spleen, and an abnormally low white blood cell count), and secondary Sjogren's (an autoimmune disorder that damages moisture-producing glands, making it difficult to produce saliva and tears). Participants were assessed into categories with extra-articular Manifestations as yes, no and missing nos.

  At Visit 1

• Mean Number of Painful and Swollen Joints at Visit 1

  Participants were assessed for painful and swollen joints at Visit 1. Painful joint is the most specific clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue.

  At Visit 1

• Physician's Global Assessment of Disease Activity at Visit 1

  The Physician's global assessment of disease activity is assessed using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity).

  At Visit 1

• Patient's Global Assessment of Disease Activity at Visit 1

  Patient global assessment of disease activity visual analog scale is assessed using a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity).

  At Visit 1

• Number of Participants With Hematology Parameters Values Falling Within Reference Values at Visit 1

  Hematology parameters are considered as one of the component of clinical characteristics. Hematology parameters included white blood cells (WBC), platelets, red blood cells (RBC), hemoglobin, hematocrit, neutrophils, basophils, eosinophils, lymphocytes, monocytes.

  At Visit 1

• Number of Participants With Biochemistry Parameters Values Falling Within Reference Values at Visit 1

  Biochemistry parameters is considered as one of the component of clinical characteristics. Biochemistry parameters included alanine amino transferase (ALT), aspartate amino transferase (AST), triglycerides, total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), and total lipids.

  At Visit 1

• Number of Participants With Presence/Absence Rheumatoid Factor and Anti-Cyclic Citrullinated Protein Antibodies

  Rheumatoid Factor (RF) is the auto antibody directed against Immunoglobulin G and its concentration is observed in human serum or plasma. Anti-Cyclic Citrullinated Protein Antibodies (Anti-CCP) antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants.

  At Visit 1

• Number of Participants With C-reactive Protein and Erythrocyte Sedimentation Rate Falling Within Reference Values at Visit 1

  The test for C-reactive Protein (CRP) is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Erythrocyte sedimentation rate (ESR) is a laboratory test that provides a non-specific measure of inflammation. A higher rate is consistent with inflammation.

  At Visit 1

• Patient Pain Visual Analog Scale Score at Visit 1

  Participants assessed their pain using a 0 to 10 horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 and is described as "no pain" and the right-hand extreme equals 10 as "unbearable pain"

  At Visit 1

• Number of Participants With Joint Damage at Visit 1

  Number of participants with joint damage is recorded as yes and no.

  At Visit 1

• Mean Score on Disease Activity Score Based on 28-Joints Count at Visit 1

  Disease activity score (DAS) 28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening.

  At Visit 1

• Number of Participants With Disease Activity Score by Categorization at Visit 1

  DAS28 is divided into 4 categories as: remission \<2.6, low activity 2.6-3.2, moderate 3.2-5.1 and high \>5.1.

  At Visit 1

• Mean Score on Clinical Disease Activity Index at Visit 1

  Clinical disease activity index (CDAI) of participants is a composite index that is calculated as the sum of number of painful joint, number of swollen joint, patient's VAS (0-10 cm) assessment, physician global VAS assessment (0-10 cm). The CDAI score ranges from 0 to 76, where lower scores indicate less disease activity.

  At Visit 1

• Number of Participants With Clinical Disease Activity by Categorization at Visit 1

  CDAI is divided into 4 categories as: remission \<2.8, low activity 2.8-10, moderate 10-22 and high\>22.

  At Visit 1

• Mean Score on Simple Disease Activity Index at Visit 1

  Simple Disease Activity Index (SDAI) is calculated by sum of number of painful joint and swollen joint count, patient and physician global assessment of disease activity (VAS 0-10 cm), and level of C-reactive protein in milligrams per deciliter (mg/dL). SDAI total score ranges from 0 to 86, where higher scores indicates greater affect due to disease activity.

  At Visit 1

• Number of Participants With Simple Disease Activity Index Score by Categorization at Visit 1

  SDAI is divided into 4 categories as: remission (\<3.3), low activity (3.3-11), moderate activity (11-26) and high activity (\>26).

  At Visit 1

Secondary Outcomes (25)

• Number of Participants Prescribed First Synthetic Disease-Modifying Antirheumatic Drug Therapy Before the Study

  At Visit 1

• Mean Time Between Diagnosis and Prescription of First Synthetic Disease-Modifying Antirheumatic Drug or First Biologic Disease-Modifying Antirheumatic Drug

  At Visit 1

• Number of Participants Who Received Each sDMARD Before The Study

  At Visit 1

• Number of Participants Who Received Last sDMARD Prescribed Before the Study

  At Visit 1

• Number of Participants Prescribed First bDMARD Before the Study

  At Visit 1

Study Arms (1)

bDMARD Monotherapy

Patients with moderate to severe rheumatoid arthritis (RA) will be treated with bDMARD (biologic disease-modifying antirheumatic drug) monotherapy under routine clinical practice conditions at rheumatology clinics

Eligibility Criteria

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

Study Population

Patients with moderate to severe rheumatoid arthritis

You may qualify if:

• Adult patients, \>/=18 years of age
• Patients with moderate to severe rheumatoid arthritis who have had an inadequate response or intolerance to disease modifying antirheumatic drugs (DMARDs) or other biological drugs
• Patients treated with biologic DMARDs alone for at least 6 months

You may not qualify if:

• Patients not willing or unable to give written informed consent for participation in this study
• Patients who are participating in any clinical trial at the time of this study

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (41)

Unknown Facility

Vitoria-Gasteiz, Alava, 01009, Spain

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Alicante, Alicante, 03010, Spain

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Elche, Alicante, 03203, Spain

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Zafra, Badajoz, 06300, Spain

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Ibiza Town, Balearic Islands, 07800, Spain

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Inca, Balearic Islands, 07300, Spain

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Manacor (Islas Baleares), Balearic Islands, 07500, Spain

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Sabadell, Barcelona, 08208, Spain

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Viladecans, Barcelona, 08840, Spain

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Burgos, Burgos, 06006, Spain

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Cáceres, Caceres, 10310, Spain

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Jerez de la Frontera, Cadiz, 11407, Spain

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Vinaròs, Castellon, 12500, Spain

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Córdoba, Cordoba, 14001, Spain

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Girona, Girona, 17007, Spain

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Cenes de la Vega, Granada, 18190, Spain

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Granda, Granada, 18190, Spain

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Donostia / San Sebastian, Guipuzcoa, 20080, Spain

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Jaén, Jaen, 23007, Spain

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A Coruña, La Coruña, 15006, Spain

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Alcalá de Henares, Madrid, 28805, Spain

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Madrid, Madrid, 28006, Spain

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Madrid, Madrid, 28007, Spain

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Madrid, Madrid, 28034, Spain

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Madrid, Madrid, 28222, Spain

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Madrid, Madrid, 28905, Spain

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Benalmádena, Malaga, 29630, Spain

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Málaga, Malaga, 29005, Spain

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Murcia, Murcia, 30008, Spain

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Palencia, Palencia, 34005, Spain

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Vigo, Pontevedra, 36214, Spain

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Oviedo, Principality of Asturias, 33006, Spain

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Seville, Sevilla, 41013, Spain

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Seville, Sevilla, 41018, Spain

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Santa Cruz de Tenerife, Tenerife, 38010, Spain

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Toledo, Toledo, 45004, Spain

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Gandia, Valencia, 46700, Spain

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Valencia, Valencia, 46015, Spain

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Valladolid, Valladolid, 47005, Spain

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Zamora, Zamora, 49022, Spain

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Zaragoza, Zaragoza, 50009, Spain

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MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

+41 616878333

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2012
• First Posted: August 14, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: April 4, 2016
• Results First Posted: April 4, 2016

Record last verified: 2016-03

Locations

ES (41)