Know Cancer

forgot password

Evaluation of the Role of Adalimumab on Extraarticular Manifestation - Bone Metabolism and Bone Mineral Density in Patients With Active Rheumatoid Arthritis

18 Years
Open (Enrolling)
Rheumatoid Arthritis, Osteoporosis

Thank you

Trial Information

Evaluation of the Role of Adalimumab on Extraarticular Manifestation - Bone Metabolism and Bone Mineral Density in Patients With Active Rheumatoid Arthritis

Follow-up of patients enables 4 patient visits during this period. Screening/Inclusion
Visit is performed when the decision to start anti Tumor Necrosis Factor-alfa therapy is
made. Inclusion of patient will succeed at day 0 (Screening/Inclusion Visit). The Second
Visit follows 3 month after the Screening/Inclusion Visit. The Third and Fourth Visits are
taking place at the month 12 and month 24 of the patient treatment. For these reasons, the
most likely visits are defined as "S/V", "V1", "V2", "V3". The end point is an evidence of
prevention of generalized bone loss in patients with active Rheumatoid Arthritis treated
with Humira® in pragmatic prescribing situations.

Inclusion Criteria:

- Patients with active early and long-standing RA (rheumatoid arthritis) according to
ACR (American College of Rheumatology) 1987 revised criteria.

- Patients with high disease activity {DAS28 (Assessment of Disease Activity) >5.1
according to the Czech Rheumatological Society criteria}.

- Patients must fulfill national guidelines for use of anti-Tumor Necrosis Factor:

- inadequate clinical response to at least one DMARD (methotrexate,
sulphasalazine, leflunomide, hydroxychloroquine, or combinations) and oral
glucocorticoids (equivalent to at least 5 mg prednisolone per day),

- Chest X-ray, PPD-skin test, Quantiferon/TB Gold test if available negative for

Exclusion Criteria:

- Patients who have had a history of Tumor Necrosis Factor blocking or rituximab

- Patients who are being treated or will be treated with drug at risk of interaction
with Humira ®.

- Pregnant female and/or female without adequate method of contraception. Patients who
didn't receive prior DMARD (Disease-modifying antirheumatic drugs) therapy.

- Patients participating in another study or clinical trial.

- Patients with severe osteoporosis {T-score (number that indicates whether or not bone
loss has occurred) of ≤ -2.5 and/or prior vertebral fracture/s/}.

- Patients with a history of total hip replacement of both extremities.

- Patients who currently receive and/or received bone metabolism modulating agents
including SERMs (Selective Estrogen Receptor Modulators), bisphosphonates,
parathyroid hormone or anti-RANKL (receptor activator of nuclear factor-kappaB
ligand) therapy.

- Subjects who are not eligible for TNF - blocking therapy according to the Czech
National Registry ( ATTRA).

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome Measure:

Bone densitometry (DEXA),

Outcome Time Frame:

Day 0, Month 12. Month 24

Safety Issue:


Principal Investigator

Ladislav Senolt, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rheumatological Institute, Prague, Czech republic


Romania: Ethics Committee

Study ID:




Start Date:

March 2009

Completion Date:

July 2014

Related Keywords:

  • Rheumatoid Arthritis
  • Osteoporosis
  • Bone mineral density
  • Bone turnover markers
  • Rheumatoid arthritis
  • Osteoporosis
  • Arthritis
  • Arthritis, Rheumatoid
  • Osteoporosis