DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Efficacy, Safety and Tolerability of Denosumab in the Treatment of Rheumatoid Arthritis

Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: placebo (Drug); denosumab (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

Summary

This study will determine the efficacy, safety, and tolerability of denosumab (AMG 162) in the treatment of Rheumatoid Arthritis (RA).

Clinical Details

Official title: A Randomized, Double-blind, Placebo-controlled, Multi-dose Phase 2 Study to Determine the Efficacy, Safety and Tolerability of Denosumab in the Treatment of Rheumatoid Arthritis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change From Baseline in Rheumatoid Arthritis Erosion Score Measured From MRI Assessments (RA-MRI ES) at Month 6

Secondary outcome:

Change From Baseline in Radiographic Total Modified Sharp Score (TSS) at Month 12

Change From Baseline in Radiographic Total Modified Sharp Score (TSS) at Month 6

Change From Baseline in Radiographic Erosion Score at Month 12

Change From Baseline in Radiographic Erosion Score at Month 6

Change From Baseline in Radiographic Joint Space Narrowing Score at Month 12

Change From Baseline in Radiographic Joint Space Narrowing Score at Month 6

Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 1

Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 6

Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12

Percent Change From Baseline in Femoral Neck Bone Mineral Density at Month 1

Percent Change From Baseline in Femoral Neck Bone Mineral Density at Month 6

Percent Change From Baseline in Femoral Neck Bone Mineral Density at Month 12

Percent Change From Baseline in Total Hip Bone Mineral Density at Month 1

Percent Change From Baseline in Total Hip Bone Mineral Density at Month 6

Percent Change From Baseline in Total Hip Bone Mineral Density at Month 12

Percent Change From Baseline in Serum Collagen C-Telopeptide (CTX) at Month 3

Percent Change From Baseline in Serum CTX at Month 6

Percent Change From Baseline in Serum CTX at Month 12

Percent Change From Baseline in Procollagen 1 N-terminal Peptide (P1NP) at Month 3

Percent Change From Baseline in P1NP at Month 6

Percent Change From Baseline in P1NP at Month 12

Percent Change From Baseline in Urine Type II Collagen C-telopeptide (C-Tx) /Creatinine at Month 3

Percent Change From Baseline in Urine Type II C-Tx /Creatinine at Month 6

Percent Change From Baseline in Urine Type II C-Tx /Creatinine at Month 12

Number of Participants With Anti-Denosumab Binding Antibodies

Number of Participants With Anti-Denosumab Binding Antibody and Neutralizing Antibody

Change From Baseline in Albumin at Month 1

Change From Baseline in Albumin at Month 3

Change From Baseline in Albumin at Month 6

Change From Baseline in Albumin at Month 12

Change From Baseline in Alkaline Phosphatase at Month 1

Change From Baseline in Alkaline Phosphatase at Month 3

Change From Baseline in Alkaline Phosphatase at Month 6

Change From Baseline in Alkaline Phosphatase at Month 12

Change From Baseline in Bicarbonate at Month 1

Change From Baseline in Bicarbonate at Month 3

Change From Baseline in Bicarbonate at Month 6

Change From Baseline in Bicarbonate at Month 12

Change From Baseline in Total Bilirubin at Month 1

Change From Baseline in Total Bilirubin at Month 3

Change From Baseline in Total Bilirubin at Month 6

Change From Baseline in Total Bilirubin at Month 12

Change From Baseline in Blood Urea Nitrogen at Month 1

Change From Baseline in Blood Urea Nitrogen at Month 3

Change From Baseline in Blood Urea Nitrogen at Month 6

Change From Baseline in Blood Urea Nitrogen at Month 12

Change From Baseline in Calcium at Month 1

Change From Baseline in Calcium at Month 3

Change From Baseline in Calcium at Month 6

Change From Baseline in Calcium at Month 12

Change From Baseline in Calcium (Corrected) at Month 1

Change From Baseline in Calcium (Corrected) at Month 3

Change From Baseline in Calcium (Corrected) at Month 6

Change From Baseline in Calcium (Corrected) at Month 12

Change From Baseline in Chloride at Month 1

Change From Baseline in Chloride at Month 3

Change From Baseline in Chloride at Month 6

Change From Baseline in Chloride at Month 12

Change From Baseline in Creatinine at Month 1

Change From Baseline in Creatinine at Month 3

Change From Baseline in Creatinine at Month 6

Change From Baseline in Creatinine at Month 12

Change From Baseline in Gamma-Glutamyl Transferase at Month 1

Change From Baseline in Gamma-Glutamyl Transferase at Month 3

Change From Baseline in Gamma-Glutamyl Transferase at Month 6

Change From Baseline in Gamma-Glutamyl Transferase at Month 12

Change From Baseline in Glucose at Month 1

Change From Baseline in Glucose at Month 3

Change From Baseline in Glucose at Month 6

Change From Baseline in Glucose at Month 12

Change From Baseline in Potassium at Month 1

Change From Baseline in Potassium at Month 3

Change From Baseline in Potassium at Month 6

Change From Baseline in Potassium at Month 12

Change From Baseline in Magnesium at Month 1

Change From Baseline in Magnesium at Month 3

Change From Baseline in Magnesium at Month 6

Change From Baseline in Magnesium at Month 12

Change From Baseline in Sodium at Month 1

Change From Baseline in Sodium at Month 3

Change From Baseline in Sodium at Month 6

Change From Baseline in Sodium at Month 12

Change From Baseline in Phosphorus at Month 1

Change From Baseline in Phosphorus at Month 3

Change From Baseline in Phosphorus at Month 6

Change From Baseline in Phosphorus at Month 12

Change From Baseline in Total Protein at Month 1

Change From Baseline in Total Protein at Month 3

Change From Baseline in Total Protein at Month 6

Change From Baseline in Total Protein at Month 12

Change From Baseline in Aspartate Amino Transferase at Month 1

Change From Baseline in Aspartate Amino Transferase at Month 3

Change From Baseline in Aspartate Amino Transferase

Change From Baseline in Aspartate Amino Transferase at Month 12

Change From Baseline in Alanine Amino Transferase at Month 1

Change From Baseline in Alanine Amino Transferase at Month 3

Change From Baseline in Alanine Amino Transferase at Month 6

Change From Baseline in Alanine Amino Transferase at Month 12

Change From Baseline in Basophils at Month 1

Change From Baseline in Basophils at Month 3

Change From Baseline in Basophils at Month 6

Change From Baseline in Basophils at Month 12

Change From Baseline in Eosinophils at Month 1

Change From Baseline in Eosinophils at Month 3

Change From Baseline in Eosinophils at Month 6

Change From Baseline in Eosinophils at Month 12

Change From Baseline in Hematocrit at Month 1

Change From Baseline in Hematocrit at Month 3

Change From Baseline in Hematocrit at Month 6

Change From Baseline in Hematocrit at Month 12

Change From Baseline in Hemoglobin at Month 1

Change From Baseline in Hemoglobin at Month 3

Change From Baseline in Hemoglobin at Month 6

Change From Baseline in Hemoglobin at Month 12

Change From Baseline in Lymphocytes at Month 1

Change From Baseline in Lymphocytes at Month 3

Change From Baseline in Lymphocytes at Month 6

Change From Baseline in Lymphocytes at Month 12

Change From Baseline in Monocytes at Month 1

Change From Baseline in Monocytes at Month 3

Change From Baseline in Monocytes at Month 6

Change From Baseline in Monocytes at Month 12

Change From Baseline in Total Neutrophils at Month 1

Change From Baseline in Total Neutrophils at Month 3

Change From Baseline in Total Neutrophils at Month 6

Change From Baseline in Total Neutrophils at Month 12

Change From Baseline in Platelets at Month 1

Change From Baseline in Platelets at Month 3

Change From Baseline in Platelets at Month 6

Change From Baseline in Platelets at Month 12

Change From Baseline in Red Blood Cells at Month 1

Change From Baseline in Red Blood Cells at Month 3

Change From Baseline in Red Blood Cells at Month 6

Change From Baseline in Red Blood Cells at Month 12

Change From Baseline in White Blood Cells at Month 1

Change From Baseline in White Blood Cells at Month 3

Change From Baseline in White Blood Cells at Month 6

Change From Baseline in White Blood Cells at Month 12

Number of Participants With Laboratory Common Terminology Criteria for Adverse Events (CTCAE) Grade Greater or Equal to 3

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of RA.

- All subjects will be required to have been taking a stable dose of methotrexate.

- Active RA at screening defined as greater than or equal to 6 swollen joints.

- The presence of erosive disease

Exclusion Criteria:

- Received any biologic agent (e. g., Enbrel®, Remicade®, Humira®, Kineret®) or Arava®

within 8 weeks before randomization; past use of these agents is allowed.

- Steroid use greater than 15 mg/day.

- Scheduled for surgery or joint replacement in the hands, wrists or feet.

Locations and Contacts

Additional Information

AmgenTrials clinical trials website

Notice regarding posted summaries of trial results

To access clinical trial results information click on this link

Related publications:

Cohen SB, Dore RK, Lane NE, Ory PA, Peterfy CG, Sharp JT, van der Heijde D, Zhou L, Tsuji W, Newmark R; Denosumab Rheumatoid Arthritis Study Group. Denosumab treatment effects on structural damage, bone mineral density, and bone turnover in rheumatoid arthritis: a twelve-month, multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial. Arthritis Rheum. 2008 May;58(5):1299-309. doi: 10.1002/art.23417.

Deodhar A, Dore RK, Mandel D, Schechtman J, Shergy W, Trapp R, Ory PA, Peterfy CG, Fuerst T, Wang H, Zhou L, Tsuji W, Newmark R. Denosumab-mediated increase in hand bone mineral density associated with decreased progression of bone erosion in rheumatoid arthritis patients. Arthritis Care Res (Hoboken). 2010 Apr;62(4):569-74. doi: 10.1002/acr.20004.

Dore RK, Cohen SB, Lane NE, Palmer W, Shergy W, Zhou L, Wang H, Tsuji W, Newmark R; Denosumab RA Study Group. Effects of denosumab on bone mineral density and bone turnover in patients with rheumatoid arthritis receiving concurrent glucocorticoids or bisphosphonates. Ann Rheum Dis. 2010 May;69(5):872-5. doi: 10.1136/ard.2009.112920. Epub 2009 Sep 3.

Newmark R.RA study--Summary of RA data and effects of denosumab on bone loss.Journal-004521;

Sharp JT, Tsuji W, Ory P, Harper-Barek C, Wang H, Newmark R. Denosumab prevents metacarpal shaft cortical bone loss in patients with erosive rheumatoid arthritis. Arthritis Care Res (Hoboken). 2010 Apr;62(4):537-44. doi: 10.1002/acr.20172.

Starting date: August 2004
Last updated: January 10, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017